NA CLASSIC (REF C-1005-S)Recalls & reported problems

St. Jude Medical, Inc. · Radiofrequency Cannula - Curved · Class 2

Quick summary

This St. Jude Medical NA Classic radiofrequency cannula has 40 adverse event reports, describing device malfunctions with no deaths and no injuries. The reports mostly mention manufacturing or shipping misassembly and labeling problems. One recall, closed, began November 2019 because a lot of cannulas was mislabeled as having a shorter active tip length.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 40
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 05415067028693), received between Nov 19, 2019 and Nov 19, 2019 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (39 reports).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

Nov 11, 2019Terminated
A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas.
Z-0720-2020 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

Device Misassembled During Manufacturing /Shipping39
Nonstandard Device2
Device Markings/Labelling Problem1

Patient problems

No Patient Involvement40

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9343992 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9343982 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9343977 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9343972 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9343970 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9343786 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9343783 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9343642 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9343637 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9343635 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9343628 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9343626 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9343611 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9343587 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9343572 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9343437 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9343078 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9342959 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9342716 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9342655 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9342644 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9342568 ↗
MalfunctionNov 19, 2019Nonstandard Device; Device Markings/Labelling Problem
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9342530 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235. UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9342499 ↗
MalfunctionNov 19, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
RELATED MANUFACTURE REF NUMBER: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235 UPON OPENING THE BOX AT THE CUSTOMER SITE, THE LABEL INDICATED A 5 MM TIP AND THE PRODUCT INSIDE WAS A 10 MM TIP.
Patient problems: No Patient Involvement
MAUDE report 9342493 ↗

Device details

UDI-DI	`05415067028693`
Brand	NA
Model	CLASSIC
Catalog no.	C-1005-S
Company	St. Jude Medical, Inc.
Product code	GXI · PROBE, RADIOFREQUENCY LESION
Class	Class 2
FDA submission	K090955
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 3, 2023

Device type (GMDN): Percutaneous radio-frequency ablation probe cannula, single-use

A rigid tube designed to provide percutaneous (through the skin) tissue access through its lumen for an electrosurgical probe during radio-frequency (RF) ablation procedures (typically of peripheral nerves to treat chronic pain) and for the injection/aspiration of fluids (e.g., local anaesthetic agents). It is made of metal (e.g., stainless steel), covered in insulation except for its distal tip, and includes a plastic hub; it is available in a variety of diameters and distal tip lengths/configurations. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.