Pacel™ 401761Recalls & reported problems
St. Jude Medical Cardiovascular Division · Flow Directed Pacing Catheter · Class 2
All models of Pacel (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734021906), received between May 13, 2025 and Feb 11, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (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.
Reports received per month
Most reported problems
Device problems
- Inflation Problem1
- Material Separation1
- Pacing Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2026Pacing Problem
IT WAS REPORTED THAT THE PACEL FLOW DIRECTED PACING CATHETER WAS NOT PACING WHILE THE BALLOON WAS INFLATED. THE PATIENT WAS EXPERIENCING LOSS OF CAPTURE AND BECAME HEMODYNAMICALLY UNSTABLE. THE PHYSICIAN WAS NOTIFIED AND AN ATTEMPT WAS MADE TO REPOSITION THE TRANSVENOUS PACING LINE WITHOUT SUCCESS. THE PACING CATHETER WAS REPLACED TO RESOLVE THE ISSUE. FURTHER INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24314028 ↗MalfunctionMay 13, 2025Inflation Problem; Material Separation; Inflation Problem; Material Separation
DURING THE PROCEDURE, THE BALLOON WAS PROPERLY DEFLATED, BUT DURING REMOVAL, IT WAS FOUND THAT THE BALLOON WAS CRACKED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22014605 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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