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NA DRG (REF MN13650)Recalls & reported problems

St. Jude Medical, Inc. · Big Curve Delivery Sheath Kit · Class 3

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 05415067027207), received between Dec 17, 2018 and Dec 17, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Material Fragmentation1

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.

  • MalfunctionDec 17, 2018Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT DURING A PROCEDURE TO PLACE DRG TRIAL LEADS, THE TIP OF THE SHEATH APPEARED TO HAVE BEEN SHEARED OFF AND REMAINED INSIDE THE PATIENT. THERE WERE NO CONSEQUENCES TO THE PATIENT. NO INTERVENTION TO RETRIEVE THE DEVICE IS PLANNED AT THIS TIME.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8170336 ↗

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Sources and updates

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