N/A (REF D6-DR-005-RT)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885825000875), received between Apr 26, 2021 and Nov 12, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (2 reports).

29 other recalls cover devices cleared under the same FDA submission (K012708); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2024Device Damaged Prior to Receipt by User; Use of Device Problem; Mechanical Jam; Device Damaged Prior to Receipt by User; Use of Device Problem; Mechanical Jam

  IT WAS REPORTED, THAT THE DYNAMIC DECA CATHETER. LOST ITS ABILITY TO KEEP THE CURVE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES, THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663742 ↗
• MalfunctionJun 7, 2024Device Damaged Prior to Receipt by User; Use of Device Problem; Mechanical Jam; Device Damaged Prior to Receipt by User; Use of Device Problem; Mechanical Jam

  IT WAS REPORTED THAT THE CATHETER LOST ITS ABILITY TO KEEP A CURVE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488309 ↗
• InjuryApr 26, 2021Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THERE WAS A COMPLICATION DURING AN ABLATION PROCEDURE CONDUCTED (B)(6) 2021, WITH A RETAINED KNOTTED LEFT FEMORAL VEIN CATHETER. THE CATHETER WIRES ENTANGLED AND HAD TO BE SURGICALLY REMOVED. THE REPORTED ISSUE OCCURRED 10 MINUTES INTO THE PROCEDURE. THERE WAS EXTENDED PROCEDURE TIME REPORTED. HOWEVER, THE LENGTH OF THE EXTENDED PROCEDURE TIME WAS NOT REPORTED. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY AS THE ABLATION PROCEDURE WAS ABORTED AND HAD TO BE RESCHEDULED. IT WAS REPORTED THE PATIENT HAD NO RESIDUAL ISSUE POST REMOVAL. FOLLOWING THE ABORTED PROCEDURE, IT WAS REPORTED THE PATIENT HAD AN EPISODE OF A-FIB SINCE LEAVING THE HOSPITAL. THE PATIENT HAD THE RESCHEDULED ABLATION PROCEDURE DONE (B)(6) 2021. THE RESCHEDULED PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Atrial Fibrillation

  MAUDE report 11729173 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012708. One submission often covers many models, so check the product and lot details in each record.

• Z-2175-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2187-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2193-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2199-2026 · Apr 10, 2026 · Open, Classified
  Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2179-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2176-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2194-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2192-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2186-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2184-2026 · Apr 10, 2026 · Open, Classified
  CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2198-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2190-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2180-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2183-2026 · Apr 10, 2026 · Open, Classified
  BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2189-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER

…and 14 more.