NA 5492ALRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169889668), received between Jun 22, 2022 and May 19, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT CABLE WAS FRAYED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042408 ↗
• MalfunctionMay 19, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT CABLE WAS FRAYED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042392 ↗
• MalfunctionMay 19, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT CABLE WAS FRAYED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042340 ↗
• MalfunctionMay 19, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT CABLE WAS FRAYED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042323 ↗
• MalfunctionJul 5, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT CABLE FAILED TO CAPTURE AND PACING DID NOT OCCUR WHEN IN USE WITH THE EXTERNAL PULSE GENERATOR (EPG) CONNECTED TO THE PATIENT POST-OPERATIVELY. IT WAS NOTED THAT THE ISSUE WAS EXPERIENCED WHEN THE EPG WAS MOVED FROM THE PATIENT'S CHEST TO HANG NEXT TO THE BEDSIDE. IT WAS FURTHER NOTED THAT THE PACING WIRES WERE APPROPRIATELY SCREWED INTO THE LEAD PORTS. THE PATIENT WAS NOT PACING DEPENDENT AND HAD A SLOW ESCAPE. THE ISSUE WAS EXPERIENCED WITH TEN PATIENT CABLES IN TOTAL WITH MULTIPLE EPG'S USED. THE CUSTOMER SWITCHED TO USING DIFFERENT MODEL PATIENT CABLES WHICH RESOLVED THE ISSUE AND PACING RESUMED. UPON FURTHER INVESTIGATION, THE CUSTOMER CONSIDERED THAT THE WEAKNESS WAS NEAR THE STRAIN RELIEF PORTION OF THE PATIENT CABLES WITH LOSS OF CONNECTION IN OR NEAR THE SOCKET. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14912715 ↗
• MalfunctionJul 5, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THAT THE PATIENT CABLE FAILED TO CAPTURE AND PACING DID NOT OCCUR WHEN IN USE WITH THE EXTERNAL PULSE GENERATOR (EPG) CONNECTED TO THE PATIENT POST-OPERATIVELY. IT WAS NOTED THAT THE ISSUE WAS EXPERIENCED WHEN THE EPG WAS MOVED FROM THE PATIENT'S CHEST TO HANG NEXT TO THE BEDSIDE. IT WAS FURTHER NOTED THAT THE PACING WIRES WERE APPROPRIATELY SCREWED INTO THE LEAD PORTS. THE PATIENT WAS NOT PACING DEPENDENT AND HAD A SLOW ESCAPE. THE ISSUE WAS EXPERIENCED WITH TEN PATIENT CABLES IN TOTAL WITH MULTIPLE EPG'S USED. THE CUSTOMER SWITCHED TO USING DIFFERENT MODEL PATIENT CABLES WHICH RESOLVED THE ISSUE AND PACING RESUMED. UPON FURTHER INVESTIGATION, THE CUSTOMER CONSIDERED THAT THE WEAKNESS WAS NEAR THE STRAIN RELIEF PORTION OF THE PATIENT CABLES WITH LOSS OF CONNECTION IN OR NEAR THE SOCKET. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14912605 ↗
• MalfunctionJul 5, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT CABLE FAILED TO CAPTURE AND PACING DID NOT OCCUR WHEN IN USE WITH THE EXTERNAL PULSE GENERATOR (EPG) CONNECTED TO THE PATIENT POST-OPERATIVELY. IT WAS NOTED THAT THE ISSUE WAS EXPERIENCED WHEN THE EPG WAS MOVED FROM THE PATIENT'S CHEST TO HANG NEXT TO THE BEDSIDE. IT WAS FURTHER NOTED THAT THE PACING WIRES WERE APPROPRIATELY SCREWED INTO THE LEAD PORTS. THE PATIENT WAS NOT PACING DEPENDENT AND HAD A SLOW ESCAPE. THE ISSUE WAS EXPERIENCED WITH TEN PATIENT CABLES IN TOTAL WITH MULTIPLE EPG'S USED. THE CUSTOMER SWITCHED TO USING DIFFERENT MODEL PATIENT CABLES WHICH RESOLVED THE ISSUE AND PACING RESUMED. UPON FURTHER INVESTIGATION, THE CUSTOMER CONSIDERED THAT THE WEAKNESS WAS NEAR THE STRAIN RELIEF PORTION OF THE PATIENT CABLES WITH LOSS OF CONNECTION IN OR NEAR THE SOCKET. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14912592 ↗
• MalfunctionJun 22, 2022Failure to Capture; Material Integrity Problem; Failure to Capture; Material Integrity Problem

  IT WAS REPORTED THAT WHEN IT WAS ATTEMPTED TO USE THE PATIENT CABLE IT WAS UNABLE TO CAPTURE RENDERING IT UNUSABLE. IT WAS NOTED THAT THE PATIENT CABLE WAS CHANGED OUT TO A DIFFERENT PRODUCT WHICH FUNCTIONED PROPERLY TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14775013 ↗
• MalfunctionJun 22, 2022Failure to Capture; Material Integrity Problem; Failure to Capture; Material Integrity Problem

  IT WAS REPORTED THAT WHEN IT WAS ATTEMPTED TO USE THE PATIENT CABLE IT WAS UNABLE TO CAPTURE RENDERING IT UNUSABLE. IT WAS NOTED THAT THE PATIENT CABLE WAS CHANGED OUT TO A DIFFERENT PRODUCT WHICH FUNCTIONED PROPERLY TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14774946 ↗
• MalfunctionJun 22, 2022Failure to Capture; Material Integrity Problem; Failure to Capture; Material Integrity Problem

  IT WAS REPORTED THAT WHEN IT WAS ATTEMPTED TO USE THE PATIENT CABLE IT WAS UNABLE TO CAPTURE RENDERING IT UNUSABLE. IT WAS NOTED THAT THE PATIENT CABLE WAS CHANGED OUT TO A DIFFERENT PRODUCT WHICH FUNCTIONED PROPERLY TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14774653 ↗