SJM™ 405254Recalls & reported problems
St. Jude Medical, Inc. · Peel-Away Introducer · Class 2
All models of SJM (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734204590), received between Sep 26, 2019 and Sep 26, 2019 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 26, 2019Material Fragmentation; Material Fragmentation
DURING A PROCEDURE A DEVICE FRAGMENTATION OCCURRED. AT THE END OF THE CASE, AS THE SHEATH WAS BEING PEELED, THE SHEATH STRETCHED INSTEAD OF PEELED AND THE MATERIAL TORE LEAVING APPROXIMATELY 4 INCHES OF THE DEVICE IN THE PATIENT. A SMALL DERMATOTOMY WAS DONE TO INSERT FORCEPS TO RETRIEVE THE REMAINING PORTION OF THE DEVICE. ALL PIECES WERE REMOVED FROM THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9125380 ↗
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- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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