N/A (REF 402004)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885825007744), received between Mar 11, 2020 and Mar 4, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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.

• 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 CHALLENGI

  Patient problems: Abdominal Pain; Cardiac Perforation; Pericardial Effusion

  MAUDE report 21518468 ↗
• MalfunctionDec 27, 2024Use of Device Problem; Difficult to Open or Remove Packaging Material; Mechanical Jam; Use of Device Problem; Difficult to Open or Remove Packaging Material; Mechanical Jam

  IT WAS REPORTED THE QUAD CATHETER ARE NOT SLIDING OUT OF THEIR PACKAGING TUBES VERY WELL. AS REPORTED, WERE GETTING STUCK TO THE POINT THAT THE CURVE ON TH END OF THE CATHETERS ARE BEING STRAIGHTENED OUT. IN PARTICULAR, THE CRD-2 ARE MOST AFFECTED. NO INFORMATION WAS PROVIDED REGARDING PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027503 ↗
• MalfunctionMar 11, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CATHETER WAS BENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9821180 ↗

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-2198-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2188-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2181-2026 · Apr 10, 2026 · Open, Classified
  BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2190-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2195-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2189-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2176-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2199-2026 · Apr 10, 2026 · Open, Classified
  Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2184-2026 · Apr 10, 2026 · Open, Classified
  CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2185-2026 · Apr 10, 2026 · Open, Classified
  CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2193-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2191-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2196-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2194-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2179-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER

…and 14 more.