N/A (REF 81104)Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00885825009557), received between Nov 29, 2017 and Apr 2, 2026 — classified as 2 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (30 reports).

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 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Mechanical Problem; Use of Device Problem

  IT WAS REPORTED THE DEFLECTION OF A CATHETER DOES NOT WORK. 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 24771701 ↗
• MalfunctionJan 9, 2026Mechanical Problem; Use of Device Problem

  IT WAS REPORTED THAT THE DEVICE WAS BAD. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME WAS REPORTED HOWEVER THE COMPLAINANT IS NOT AWARE OF THE DURATION. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019812 ↗
• MalfunctionDec 22, 2025Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED THE EP CATHETER IS NOT DEFLECTING CORRECTLY. 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 23870698 ↗
• MalfunctionDec 17, 2025Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED THAT THE EP CATHETER HAS AN INCORRECT 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 23834030 ↗
• MalfunctionAug 12, 2025Use of Device Problem; Deformation Due to Compressive Stress; Use of Device Problem; Deformation Due to Compressive Stress

  IT WAS REPORTED THE EP CATHETER FAILED. AS REPORTED, THE DEVICE WAS REPLACED WITH A STRYKER DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME WAS REPORTED, HOWEVER THE COMPLAINANT IS NOT AWARE OF THE DURATION. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783749 ↗
• MalfunctionJun 6, 2025Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE UPON OPENING. AS REPORTED, THE DEFLECTION WAS BROKEN. 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 22161286 ↗
• MalfunctionMar 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE 81104 DID NOT DEFLECT CORRECTLY. 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 21567108 ↗
• MalfunctionMar 10, 2025Device 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 HAD A WARPED CURVE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS FIVE MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21566881 ↗
• MalfunctionMar 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE ITEM 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 21562228 ↗
• MalfunctionMar 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT IT 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 21562226 ↗
• MalfunctionMar 6, 2025Device 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 CS CATHETER WAS NOT TO THE DESIGNED SHAPE. AS REPORTED, THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS FIFTEEN MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21542375 ↗
• MalfunctionMar 6, 2025Use of Device Problem; Deformation Due to Compressive Stress; Mechanical Jam; Use of Device Problem; Deformation Due to Compressive Stress; Mechanical Jam

  IT WAS REPORTED THAT THE CS CATHETER WAS NOT TO THE DESIGNED SHAPE. AS REPORTED, THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS FIFTEEN MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21542374 ↗
• MalfunctionMar 6, 2025Device 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 CS CATHETER WAS NOT TO THE DESIGNED SHAPE. AS REPORTED, THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS FIFTEEN MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21542373 ↗
• MalfunctionMar 4, 2025Use of Device Problem; Mechanical Jam; Use of Device Problem; Mechanical Jam

  IT WAS REPORTED THAT CATHETER HAD A WARPED CURVE. AS REPORTED, THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS TEN MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21516173 ↗
• MalfunctionFeb 26, 2025Device 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 HAD A DEFECTIVE CURL. AS REPORTED, THE CATHETER WAS REMOVED AND TESTED AND THE CURL WAS FOUND DEFECTIVE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND THE COMPLAINANT IS NOT AWARE OF ANY EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21474604 ↗
• MalfunctionFeb 20, 2025Use of Device Problem; Mechanical Jam; Use of Device Problem; Mechanical Jam

  IT WAS REPORTED THAT THE CATHETER HAD A WARPED CURVE. AS REPORTED, THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS FIVE MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428581 ↗
• MalfunctionFeb 5, 2025Use of Device Problem; Mechanical Jam; Use of Device Problem; Mechanical Jam

  IT WAS REPORTED THAT THE INQUIRY CATHETER HAD A WARPED CURVE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS TEN MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21317232 ↗
• MalfunctionJan 13, 2025Use of Device Problem; Deformation Due to Compressive Stress; Mechanical Jam; Use of Device Problem; Deformation Due to Compressive Stress; Mechanical Jam

  IT WAS REPORTED THAT THE DEFLECTABLE BUTTON DOESN'T WORK. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND 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 21145132 ↗
• MalfunctionDec 12, 2024Use of Device Problem; Mechanical Jam; Use of Device Problem; Mechanical Jam

  IT WAS REPORTED THAT THE CATHETER CURVED LIKE AN "S" WHEN DEFLECTED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED 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 20913938 ↗
• MalfunctionNov 26, 2024Use of Device Problem; Deformation Due to Compressive Stress; Mechanical Jam; Use of Device Problem; Deformation Due to Compressive Stress; Mechanical Jam

  IT WAS REPORTED THAT THE CATHETER HAD A WARPED 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 20777623 ↗
• MalfunctionNov 25, 2024Use of Device Problem; Deformation Due to Compressive Stress; Mechanical Jam; Use of Device Problem; Deformation Due to Compressive Stress; Mechanical Jam

  IT WAS REPORTED THAT THE CATHETER HAD A WARPED 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 20775893 ↗
• MalfunctionSep 24, 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 HAD A WARPED CURVE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS TEN MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20296094 ↗
• MalfunctionJul 18, 2024Use of Device Problem; Mechanical Jam; Use of Device Problem; Mechanical Jam

  IT WAS REPORTED THAT THE CATHETER NO LONGER HAS THE RIGHT CURVE TO FIND THE CORONARY SINUS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS FIVE TO TEN MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19773004 ↗
• MalfunctionJul 10, 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 CATHETER WHEN CURLED IN, CURLS IN AND POSTERIOR. NOT STRAIGHT BACK. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND THE COMPLAINANT IS NOT AWARE OF ANY EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715308 ↗
• MalfunctionJun 19, 2024Positioning Failure; Inadequacy of Device Shape and/or Size; Use of Device Problem; Positioning Failure; Inadequacy of Device Shape and/or Size; Use of Device Problem

  IT WAS REPORTED THAT THE CATHETER DIDN'T HAVE THE RIGHT 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 19570932 ↗