N/A (REF BD710DF282RTS)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885825000264), received between Jun 22, 2017 and Dec 4, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 reports).

27 other recalls cover devices cleared under the same FDA submission (K100254); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED THAT THE STEERABLE MECHANISM WAS EXAGGERATED ON ONE SIDE VS. THE OTHER. AS AN ILLUSTRATIVE EXAMPLE, WHEN TURNED 10 DEGREES LEFT, THE CATHETERS CURVED 25 DEGREES WHEREAS WHEN TURNED 10 DEGREES RIGHT, THE CATHETER CURVED 10 DEGREES. 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 23721799 ↗
• MalfunctionMar 10, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CATHETER IS DEFECTIVE, TIP HAS A DEFECTIVE BEND. 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 21561690 ↗
• MalfunctionOct 27, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED "NO STRUCTURE OR SUPPORT ON THE CATHETER, WET NOODLE." THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. EXTENDED PROCEDURE TIME WAS NOT REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708797 ↗
• MalfunctionApr 29, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE DEVICE DOES NOT DEFLECT PROPERLY. THE DEVICE WAS REPORTED TO NOT HAVE ANY KINKS OR BENDS. 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 11749336 ↗
• MalfunctionJan 26, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER WAS NOT DEFLECTING PROPERLY. 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 11233555 ↗
• MalfunctionOct 20, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THE EP CATHETER HAD A WARPED, ABNORMAL CURVE. THE CATHETER WAS NOT DEFLECTING ENOUGH TO THE LIKING OF THE ELECTROPHYSIOLOGIST. 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 10705264 ↗
• MalfunctionJun 25, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THERE WAS A DEFECT/BEND AT THE END OF THE CATHETER NOTED PRIOR TO THE PROCEDURE. 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 10195429 ↗
• InjuryJun 22, 2017Kinked; Scratched Material; Kinked; Scratched Material

  IT WAS REPORTED THAT THE EP CATHETER CAUSED A BLOOD CLOT DURING THE PROCEDURE. THROUGH ULTRASOUND, A CLOT WAS NOTICED TOWARD THE END OF THE PROCEDURE AND THE CATHETER WAS REMOVED. THE AREA WHERE THE CLOT WAS STUCK TO THE CATHETER WAS ROUGH/FRAYED/NICKED. IT WAS REPORTED THERE WAS A BEND/KINK NEAR THE TIP OF THE DEVICE. THE CASE WAS ENDED PREMATURELY BECAUSE OF THE CLOT, BUT THE PHYSICIAN FELT ENOUGH OF THE PROCEDURE WAS COMPLETED TO STOP WHERE THEY WERE. SHEATHS WERE LEFT IN, HEPARIN WAS NOT REVERSED AND THE PATIENT WAS PUT ON BED REST IN RESPONSE TO THE FORMATION OF A BLOOD CLOT. IMMEDIATE POST OPERATIVE ASSESSMENTS WERE NORMAL. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Thrombus

  MAUDE report 6662479 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100254. One submission often covers many models, so check the product and lot details in each record.

• Z-2184-2026 · Apr 10, 2026 · Open, Classified
  CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2175-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2193-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2198-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2177-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
• Z-2183-2026 · Apr 10, 2026 · Open, Classified
  BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2197-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2187-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2196-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2189-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2192-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2191-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401904; 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-2182-2026 · Apr 10, 2026 · Open, Classified
  BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER

…and 12 more.