MalfunctionLDF
PACEL BIPOLAR PACING CATHETER
Received Apr 9, 2026 · Event occurred Mar 16, 2026
Report 3004742232-2026-00087 · MDR key 24834870
Device
Generic name
Electrode, Pacemaker, Temporary
Manufacturer
Abbott MedicalModel number
401763Catalog number
401763
Lot number
11125572
Product problems
- Inflation Problem
- Gas/Air Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT DURING PROCEDURE A PACEL BALLOON ON THE BIPOLAR PACING CATHETER APPEARED TO BE LEAKING AND COULD NOT BE INFLATED.