N/A (REF 201101)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00885825003845), received between Nov 6, 2018 and Mar 23, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

27 other recalls cover devices cleared under the same FDA submission (K030187); 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.

Recalls naming this device

1. Apr 10, 2026Open, Classified

   Incomplete seals on sterile product

   Z-2174-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Use of Device Problem

  IT WAS REPORTED CATHETER BENDING MECHANISM IS NOT FUNCTIONING PROPERLY AND DOES NOT OPERATE AS INTENDED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS A FEW MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670655 ↗
• MalfunctionSep 12, 2025Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THAT THE DYNAMIC DECA CATHETER LOST ITS CURVE MID-CASE. AS REPORTED, THE DEVICE WAS REPLACED WITH OEM. 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 23042934 ↗
• MalfunctionAug 11, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PLUNGER WAS DIFFICULT TO MANEUVER. 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 22779348 ↗
• MalfunctionAug 11, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PLUNGER WAS DIFFICULT TO MANEUVER. 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 22779345 ↗
• MalfunctionJun 25, 2025Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THAT A DUODECA CATHETER WAS USED IN A CASE AND THE DOCTOR BELIEVED THERE WAS SOMETHING WRONG WITH THE CURVE OF THE CATHETER AND HAD ISSUES MANIPULATING IT. THE COMPLAINANT IS NOT AWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22332942 ↗
• MalfunctionJan 15, 2025Fracture; Mechanical Problem; Use of Device Problem; Fracture; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED THAT CATHETER TIP WAS NOT DEFLECTING AND THAT IT WAS POSSIBLY 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21162078 ↗
• MalfunctionAug 21, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THE DEVICE WAS BROKEN AS THE CURL HAD A GOOSE NECK SHAPE. HOWEVER, IT WAS ALSO REPORTED THAT THE DEVICE WAS NEVER PUT IN-SITU AND THERE WAS NO HARM TO PATIENT. THE COMPLAINANT IS NOT AWARE OF ANY MEDICAL INTERVENTION OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17592717 ↗
• MalfunctionOct 4, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE CATHETER WAS, "WORN OUT, DOES NOT STEER." THE DEVICE WAS REPLACED WITH ANOTHER. 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 12573654 ↗
• MalfunctionJul 1, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE CATHETER DID NOT DEFLECT 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 12104637 ↗
• MalfunctionJun 21, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED PRIOR TO THE ABLATION PROCEDURE, THE DOCTOR TRIED TO DEFLECT THE CATHETER AND THE EP DID NOT RESPOND AS EXPECTED. THE CURVE HE GOT WAS NOT AS HE EXPECTED AS WELL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. EXTENDED PROCEDURE TIME WAS REPORTED TO BE A FEW MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037845 ↗
• MalfunctionJun 21, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED PRIOR TO THE ABLATION PROCEDURE, THE DOCTOR TRIED TO DEFLECT THE CATHETER AND THE EP DID NOT RESPOND AS EXPECTED. THE CURVE HE GOT WAS NOT AS HE EXPECTED AS WELL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. EXTENDED PROCEDURE TIME WAS REPORTED TO BE A FEW MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037824 ↗
• MalfunctionApr 19, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE DEVICE IS SOFT. 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 11690946 ↗
• MalfunctionMar 25, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE CATHETER IS MIS-SHAPED. THE DEVICE WAS REPLACED. 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 11569584 ↗
• MalfunctionJan 11, 2021Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER WAS UNABLE TO BE KEPT IN POSITION. 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 11151736 ↗
• MalfunctionNov 11, 2020Mechanical Problem; Inadequacy of Device Shape and/or Size; Mechanical Problem; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THE CATHETER DOES NOT MAKE PROPER CURVE WHEN TURNING. THERE WAS NO MEDICAL INTERVENTION. THE COMPLAINANT IS NOT AWARE OF ANY PATIENT INJURY, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10823096 ↗
• MalfunctionNov 2, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THE CATHETER HAS POOR STEERING. THE COMPLAINANT IS NOT AWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10771537 ↗
• MalfunctionMay 23, 2019Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE ELECTROPHYSIOLOGY CATHETER DID NOT CURVE PROPERLY. INSTEAD OF A C CURVE IT LOOKED LIKE IT WAS BENT OUT OF SHAPE. THE ELECTROPHYSIOLOGY CATHETER WAS NOT DEFLECTING ENOUGH. 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 8637435 ↗
• MalfunctionNov 6, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER WAS NON-FUNCTIONAL. 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 8042422 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030187. One submission often covers many models, so check the product and lot details in each record.

• Z-0085-2027 · Aug 18, 2026 · Open, Classified
  BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
• 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-2180-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2192-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2178-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2194-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2188-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• 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-2175-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2190-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2197-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2191-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2189-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER

…and 12 more.