SJM™ 405153Recalls & reported problems
St. Jude Medical, Inc. · Class 2
Data updated Oct 13, 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 05414734204408), received between Mar 26, 2020 and Mar 26, 2020 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 3005334138-2020-00124. DURING A CRT-D IMPLANT PROCEDURE, THE SUBCLAVIAN VEIN WAS PERFORATED. WHEN ACCESS TO THE SUBCLAVIAN VEIN WAS BEING PERFORMED, SEVERAL PUNCTURES WERE REQUIRED BUT WERE NOT SUCCESSFUL. THE VEIN WAS PERFORATED SEVERAL TIMES AND THE PATIENT'S CONDITION WORSENED WITH BLOOD NOTED TO BE COMING FROM THE MOUTH. THE PATIENT WAS INTUBATED AND REQUIRED VENTILATION SUPPORT, EVENTUALLY BEING TRANSFERRED TO THE SURGICAL OPERATING ROOM IN UNSTABLE CONDITION. OPEN CHEST SURGERY WAS REQUIRED TO STOP THE BLEEDING. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.
Patient problems: Perforation
MAUDE report 9884928 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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