Pacel™ 401762Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734001045), received between Jun 24, 2019 and Mar 9, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2022Pacing Problem; Improper or Incorrect Procedure or Method; Pacing Problem; Improper or Incorrect Procedure or Method

  FOLLOWING A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE, IN THE EVENING THE PATIENT WAS BROUGHT IN FOR A TEMPORARY LEAD IMPLANT WITH AN EXTERNAL PACEMAKER. THE PATIENT WAS NOTED TO BE DISPLAYING BRADYCARDIA WITH A HEARTBEAT OF 38 BEATS/MINUTE WITH LABILITY. FOLLOWING THE PROCEDURE, THE PATIENT WENT INTO CARDIO-RESPIRATORY ARREST AND WAS SENT FOR CARDIAC RESUSCITATION. THE PATIENT WAS THEN RECOVERED VIA CARDIAC MASSAGE. IT WAS NOTED THAT THE TEMPORARY LEAD HAD NOT BEEN FUNCTIONING. THE EXTERNAL PACEMAKER AND THE LEAD CABLE WERE EXCHANGED, AND THEN THE TEMPORARY LEAD WAS REPOSITIONED, BUT THE TEMPORARY LEAD STILL ONLY FUNCTIONED INTERMITTENTLY. THE TEMPORARY LEAD WAS NOTED TO BE FIXED TO THE PATIENT BY BEING SUTURED TO THE SKIN. THIS WAS THEN DETERMINED TO BE THE ISSUE AS THE SUTURES WERE OVERTIGHTENED AND CAUSED THE CONDUCTOR TO BREAK AND THE CATHETER NOT TO PACE. THE PATIENT WAS IMPLANTED WITH A NON-ABBOTT SINGLE-CHAMBER PACEMAKER ON (B)(6) 2022 AND WAS DISCHARGED ON (B)(6) 2022 WITH NO COMPLICATIONS RELATED TO THE CARDIO-RESPIRATORY ARREST.

  Patient problems: Arrhythmia

  MAUDE report 13716862 ↗
• InjuryJun 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A VALVULOPLASTY PROCEDURE, THE DISTAL ELECTRODE ON THE CATHETER WAS LEFT INSIDE A PERIPHERAL VEIN. WHILE THE DEVICE WAS IN THE RIGHT ATRIUM, THE BALLOON WAS INFLATED AND DEFLATED. LATER, THE BALLOON WAS ATTEMPTED TO BE INFLATED, HOWEVER, X-RAY REVEALED THAT THE BALLOON WAS NOT INFLATED. WHILE EXTRACTING THE DEVICE, THE ELECTRODE WAS NOTED TO BE MISSING AND THE DEVICE WAS DAMAGED. AN X-RAY SHOWED THAT THE DISTAL ELECTRODE WAS NOT IN THE HEART BUT A PERIPHERAL VEIN, SO THE PROCEDURE WAS COMPLETED AND THE ELECTRODE WAS NOT RETRIEVED. THERE WERE NO PATIENT CONSEQUENCES AND NO INTERVENTION WAS PERFORMED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8728639 ↗