Pacel™ 401767Recalls & reported problems
St. Jude Medical Cardiovascular Division · Bipolar Pacing Catheter · Class 2
All models of Pacel (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734001076), received between Apr 18, 2019 and May 17, 2019 — classified as 3 injuries.
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
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Perforation2
- Cardiac Perforation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, A PERFORATION OCCURRED WITH EXTRACTION OF THE LEADS. THE PATIENT WAS TRANSFERRED TO SURGERY FOR REPAIR OF THE HOLE IN THE APEX. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Perforation
MAUDE report 8621745 ↗InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, A PERFORATION OCCURRED WITH EXTRACTION OF THE LEADS. THE PATIENT WAS TRANSFERRED TO SURGERY FOR REPAIR OF THE HOLE IN THE APEX. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Perforation
MAUDE report 8621735 ↗InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CATHETER WIRE PERFORATED THE HEART WALL. A 6F LEAD WAS USED WITHOUT A BALLOON. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR SURGICAL INTERVENTION. A PATCH WAS PLACED ON THE PERFORATED PART OF THE HEART. THE PATIENT IS STABLE.
Patient problems: Cardiac Perforation
MAUDE report 8528553 ↗
Other ELECTRODE, PACEMAKER, TEMPORARY devices
- N/A 006173PC. R. Bard, Inc. · ELECTRODE, PACEMAKER, TEMPORARY161 reports
- SWAN-GANZ D200F7Edwards Lifesciences LLC · ELECTRODE, PACEMAKER, TEMPORARY1 recall0 reports
- ETHICON TPW32Ethicon, LLC · ELECTRODE, PACEMAKER, TEMPORARY1 death46 reports
- ETHICON TPW20Ethicon, LLC · ELECTRODE, PACEMAKER, TEMPORARY39 reports
- N/A 520007PC. R. Bard, Inc. · ELECTRODE, PACEMAKER, TEMPORARY33 reports
- Pacel™ 401763St. Jude Medical Cardiovascular Division · ELECTRODE, PACEMAKER, TEMPORARY21 reports
- Pacel™ 401771St. Jude Medical Cardiovascular Division · ELECTRODE, PACEMAKER, TEMPORARY1 death16 reports
- SWAN-GANZ PACING TD CATHETER D205F7Edwards Lifesciences LLC · Electrode, Pacemaker, Temporary13 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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