NA 5103Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169838604), received between Sep 20, 2019 and Jul 25, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (1 report).

10 other recalls cover devices cleared under the same FDA submission (P890003); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2024No Device Output; Material Twisted/Bent; No Device Output; Material Twisted/Bent

  IT WAS REPORTED THAT THE ADAPTER CABLE HAD A BENT PIN AND WAS UNABLE TO PROPERLY CONNECT TO THE MOBILE PROGRAMMER BASE. IT WAS NOTED THAT THE PACING FROM THE ANALYSER WAS NOT POSSIBLE WHEN THE PATIENT WAS IN ASYSTOLE. IT WAS FURTHER NOTED THAT EXTERNAL PACING WAS REQUIRED AND THE LEAD WAS ATTACHED TO A GENERATOR TO PROVIDE EMERGENCY PACING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole

  MAUDE report 19826417 ↗
• MalfunctionJan 31, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING IMPLANT THE RIGHT ATRIAL (RA) LEAD WAS NOT SENSING AND ONLY NOISE/ARTIFACT WAS NOTED TO BE VISIBLE ON TH E ELECTROGRAMS (EGM). THE RA LEAD WAS THEN TESTED THROUGH THE VENTRICULAR CHANNEL AND NO SENSING WAS NOTED. THE PROGRAMMER WAS EXCHANGED AND IT WAS NOTED THAT THE PINS OF THE ADAPTER CABLE WERE DAMAGED, THE ADAPTER CABLE WAS REPLACED BUT NO SENSING WAS OBSERVED. THE RA LEAD WAS ATTEMPTED NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18616530 ↗
• MalfunctionSep 8, 2022Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE PROGRAMMER WAS UNABLE TO MEASURE IMPEDANCE PROPERLY. IT WAS NOTED THAT IMPEDANCE WAS BEING DISPLAYED AS GREAT THAN 4000 OHMS FOR EVERY MEASUREMENT. IT WAS SPECULATED THAT THE ISSUE MAY HAVE BEEN DUE TO A DEFECTIVE Y ADAPTER. IMPEDANCE WAS SUCCESSFULLY MEASURED USING A NON COMPANY PROGRAMMER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15377674 ↗
• InjurySep 20, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AFTER THE RIGHT VENTRICULAR (RV) LEAD WAS PLACED, TESTING OF THE LEAD WAS ATTEMPTED USING THE ANALYZER AND THE ADAPTER CABLES. PACING WAS UNABLE TO BE DELIVERED TO THE PATIENT WHILE ATTEMPTING TO TEST THE LEAD. THE PATIENT'S HEART DROPPED DOWN TO 17 BEATS PER MINUTE. THIS WAS RESOLVED BY PLUGGING THE LEAD DIRECTLY INTO THE IMPLANTABLE PULSE GENERATOR (IPG). AFTER INSPECTING THE ADAPTER CABLE, IT WAS NOTED THAT THE PRONGS HAD BEEN DAMAGED WHEN IT WAS PLUGGED INTO THE ANALYZER. THE PATIENT SUFFERED ARRHYTHMIA AND HEART BLOCK. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Complete Heart Block

  MAUDE report 9100774 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P890003. One submission often covers many models, so check the product and lot details in each record.

• Z-2168-2025 · Jun 18, 2025 · Open, Classified
  Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria
• Z-2169-2025 · Jun 18, 2025 · Open, Classified
  Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria A
• Z-2127-2025 · Jun 17, 2025 · Open, Classified
  Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D
• Z-2128-2025 · Jun 17, 2025 · Open, Classified
  Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model N
• Z-2505-2020 · Jun 4, 2020 · Open, Classified
  CareLink SmartSync Device Manager, Model Number 24970A
• Z-2506-2020 · Jun 4, 2020 · Open, Classified
  Patient Connector, Model Number 24967
• Z-0845-2019 · Jan 17, 2019 · Terminated
  Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
• Z-0399-2018 · Jul 14, 2017 · Terminated
  MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with
• Z-0400-2018 · Jul 14, 2017 · Terminated
  MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates
• Z-2209-2010 · Jun 11, 2010 · Terminated
  Medtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor Model 2490C is designed to automatically gather information from the implanted heart device. This automatic w