Pacel™ 401770Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734001113), received between Oct 8, 2024 and Aug 12, 2026 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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 18, 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.

• InjuryAug 12, 2026Material Too Rigid or Stiff

  It was reported that a Pacel Bipolar Pacing Catheter was implanted due to atrial fibrillation with a slow ventricular rate (bradycardia). There was no vessel preparation and no other devices were involved. Intraoperative testing demonstrated satisfactory pacing parameters. The catheter was secured with pressure dressing, and the patient was transferred back to the ward. On postoperative day 1, 2.5 hours following Pacel electrode extraction, the patient developed hypotension. The patient¿s base rate was 130/90. Bedside ultrasound examination confirmed the presence of pericardial effusion without obvious perforation. Pericardiocentesis and drainage were performed promptly. Following the procedure, the patient's blood pressure increased, and repeat ultrasound confirmed that the pericardial effusion was no longer increasing. A drainage catheter was left in place, and the patient was admitted to the intensive care unit (ICU) for observation. On postoperative day 2, the patient's vital signs remained stable with no significant changes compared to the previous day. On (b)(6) 2026, the patient remains under observation in the ICU due to a small amount of fluid that has continued to leak fr

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50223215 ↗
• DeathOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER USING THE TEMPORARY PACING CATHETER, THE PATIENT EXPIRED. THE CAUSE OF DEATH REMAINS UNCERTAIN.

  Patient problems: Insufficient Information

  MAUDE report 20398290 ↗