N/A (REF 401443)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885825006617), received between Dec 14, 2020 and Mar 4, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Entrapment of Device” (1 report).

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

• InjuryMar 4, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION REQUIRING CARDIAC SURGERY TO CLOSE THE EFFUSION AND STABILIZE THE PATIENT OCCURRED DURING A REDO SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE. AS REPORTED, AN ABLATION CATHETER WAS USED TO ABLATE ONE AREA THEN IT WAS DECIDED TO GO TRANSSEPTAL AND THE PATIENT REPORTED ABDOMINAL DISCOMFORT. THE ICE CATHETER WAS INSERTED INTO THE RIGHT ATRIUM WHICH REVEALED A LARGE EFFUSION. ULTRASOUND MEASURED THE EFFUSION AND A PERICARDIOCENTESIS WAS PERFORMED AND PROTAMINE WAS ADMINISTERED. THE PERFORATION WAS LOCATED IN THE RIGHT VENTRICLE WHICH WAS NOTED TO BE VERY THIN AS THE SUTURES USED TO CLOSE THE PERFORATION WERE TEARING THROUGH THE TISSUE. AS REPORTED, THE PHYSICIAN FELT THE PERFORATION WAS CAUSED BY A DIAGNOSTIC CATHETER REPROCESSED BY STRYKER. THE PATIENT IS REPORTED TO BE RECOVERING WELL AND HAS SINCE BEEN DISCHARGED. PER THE STRYKER SALES REPRESENTATIVE, THE CUSTOMER CONTACT STATED IT IS UNKNOWN IF ABLATION CATHETER, CS CATHETER OR RV CATHETER CAUSED THE EFFUSION. AFTER CARDIAC SURGERY TO STOP THE BLEED, IT WAS DETERMINED THE AREA OF THE HEART HAD PAPER THIN TISSUE ALONG WITH PATIENT HISTORY OF BEING ON ANTI-COAGULANTS CREATING A CHALLENG

  Patient problems: Abdominal Pain; Cardiac Perforation; Pericardial Effusion

  MAUDE report 21518065 ↗
• InjuryDec 14, 2020Entrapment of Device; Failure to Advance; Material Deformation; Entrapment of Device; Failure to Advance; Material Deformation

  IT WAS REPORTED, "DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE RESTERILIZED CATHETER COULD NO LONGER BE ADVANCED OR RETRIEVED IN THE RIGHT VENTRICLE. UNDER X-RAY THE CATHETER APPEARED TO BE TIED IN A KNOT. THE CATHETER WAS UNABLE TO BE REMOVED SO CRYOABLATION WAS CONTINUED. AFTER THE PROCEDURE A SNARE WAS USED TO HELP STRAIGHTEN THE CATHETER. THE CATHETER WAS REMOVED WITH NO ADVERSE EFFECTS TO THE PATIENT." THERE WAS NO PATIENT INJURY REPORTED. NO INFORMATION WAS PROVIDED REGARDING EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11004397 ↗

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-2195-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2181-2026 · Apr 10, 2026 · Open, Classified
  BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2187-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2194-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2198-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2192-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2196-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2183-2026 · Apr 10, 2026 · Open, Classified
  BW Webster Duo-Decapolar, Product Number D728260RT; 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-2177-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
• Z-2180-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2190-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2174-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2193-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER

…and 14 more.