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Xcela 60M163602Recalls & reported problems

Navilyst Medical, Inc. · PICC Convenience Kit · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H96560M1636020), received between Aug 27, 2018 and Aug 27, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unraveled Material” (1 report).

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.

Most reported problems

Device problems

  • Unraveled Material1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 27, 2018Unraveled Material; Unraveled Material

    AS REPORTED, "GUIDEWIRE PACKAGED IN (PICC) KIT HAD A SMALL BARB STICKING OUT WHICH WOULD NOT ALLOW THE INTRODUCER TO PASS OVER THE WIRE." THE GUIDEWIRE WAS RETURNED TO ANGIODYNAMICS UNRAVELLED AND IN TWO PIECES. WHEN QUERIED, THE END USER HOSPITAL INDICATED THAT THEY "CUT THE GUIDEWIRE IN HALF TO COMPLETE THE INSERTION." NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7817936 ↗

Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices

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