NA 5487L (UDI 00643169307353)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169307353), received between May 31, 2018 and Oct 29, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT CABLE CONNECTOR DID NOT HOLD THE LEAD SECURELY. IT WAS NOTED THAT TWO DIFFERENT CABLES EXHIBITED THE ISSUE, WHILE A THIRD CABLE FUNCTIONED AS INTENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412550 ↗
• MalfunctionOct 29, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT CABLE CONNECTOR DID NOT HOLD THE LEAD SECURELY. IT WAS NOTED THAT TWO DIFFERENT CABLES EXHIBITED THE ISSUE, WHILE A THIRD CABLE FUNCTIONED AS INTENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23411640 ↗
• MalfunctionMay 3, 2024No Device Output; Material Integrity Problem; No Device Output; Material Integrity Problem

  IT WAS REPORTED THAT TWO EXTERNAL PULSE GENERATOR (EPG) CABLES WERE UNABLE TO PACE. CHANGING OUT THE EPG AND ANALYZER CABLES FAILED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236788 ↗
• MalfunctionMay 3, 2024No Device Output; Material Integrity Problem; No Device Output; Material Integrity Problem

  IT WAS REPORTED THAT TWO EXTERNAL PULSE GENERATOR (EPG) CABLES WERE UNABLE TO PACE. CHANGING OUT THE EPG AND ANALYZER CABLES FAILED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236750 ↗
• MalfunctionFeb 1, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO INSERT THE LEAD SECURELY INTO THE PATIENT CABLE. IT WAS NOTED THAT THE LEAD ELECTRODES WERE NOT IN PROPER CONTACT WITH THE CABLE IN ORDER TO PACE. THE CABLE WAS INADVERTENTLY DROPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18620681 ↗
• MalfunctionMay 20, 2019Failure to Capture; Material Integrity Problem; Failure to Capture; Material Integrity Problem

  THE CABLES WERE RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8624881 ↗
• MalfunctionMay 20, 2019Failure to Capture; Material Integrity Problem; Failure to Capture; Material Integrity Problem

  IT WAS REPORTED THAT THE CABLES WOULD NOT CAPTURE WHEN CONNECTED TO THE LEADS AND TO AN EXTERNAL PULSE GENERATOR (EPG). THE PHYSICIAN THEN OPTED TO CONNECT THE LEADS TO AN IMPLANTABLE PULSE GENERATOR (IPG) THAT WAS TAPED EXTERNALLY TO THE PATIENT'S NECK UNTIL A DEVICE COULD BE IMPLANTED. THE CABLES ARE EXPECTED TO BE RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8624871 ↗
• InjuryMay 31, 2018Intermittent Capture; Failure to Capture; Loose or Intermittent Connection; Intermittent Capture; Failure to Capture; Loose or Intermittent Connection

  IT WAS REPORTED THAT WHILE IN USE THE EXTERNAL PULSE GENERATOR LOST CAPTURE AND IT WAS ATTRIBUTED TO A LOOSE CONNECTION BETWEEN THE LEAD AND THE GENERATOR. THE TEMPORARY EXTERNAL PULSE GENERATOR WAS REPLACED BY A PERMANENT PULSE GENERATOR. FOLLOWING THE LOSS OF CAPTURE IT WAS NOTED THAT THE PATIENT HAD TO BE EXTERNALLY PACED. THE LEAD (CABLE) IS EXPECTED TO BE RETURNED. IT WAS NOTED THAT THE PATIENT WAS ALIVE WITH NO INJURY AND NO FURTHER PATIENT COMPLICATION HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7557725 ↗