NA 2292 (UDI 00721902307294)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00721902307294), received between Jan 16, 2019 and Mar 12, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (10 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2024Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ANALYZER SURGICAL CABLES' CONNECTORS WERE DAMAGED. IT WAS NOTED THAT THE CABLES WERE NEW AND WERE RECEIVED AND INSPECTED FOLLOWING STERILIZATION. THE USER EXPRESSED DISSATISFACTION REGARDING THE QUALITY OF THE CABLES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884039 ↗
• MalfunctionMar 12, 2024Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ANALYZER SURGICAL CABLES' CONNECTORS WERE DAMAGED. IT WAS NOTED THAT THE CABLES WERE NEW AND WERE RECEIVED AND INSPECTED FOLLOWING STERILIZATION. THE USER EXPRESSED DISSATISFACTION REGARDING THE QUALITY OF THE CABLES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884030 ↗
• MalfunctionJul 22, 2022Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE ANALYZER CABLE GAVE HIGH IMPEDANCE VALUES DURING PATIENT DEVICE LEAD MEASUREMENT. IT WAS NOTED THAT THE SENSING WAS VARIED AND THE DETECTION THRESHOLD FLUCTUATED FROM EXTREMELY HIGH TO WITHIN NORMAL RANGE. TROUBLESHOOTING STEPS WERE TAKEN TO USE AN ALTERNATIVE CABLE AND THE IMPEDANCE, DETECTION THRESHOLD AND SENSING VALUES REMAINED STEADY AND WITHIN THE NORMAL RANGE. THE CABLE RETURNED INTO SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15081980 ↗
• MalfunctionMar 31, 2022Impedance Problem; Material Integrity Problem; Impedance Problem; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO AN IMPLANT PROCEDURE, THE  ANALYZER SURGICAL CABLE EXHIBITED HIGH IMPEDANCE WHEN TESTING VIA A SHORT CIRCUIT. THE ANALYZER WAS REPLACED BUT HIGH IMPEDANCE VALUES WERE STILL EXHIBITED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13963408 ↗
• MalfunctionNov 30, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO MEASURE SIGNALS FROM THE LEAD WITH THE ANALYZER SURGICAL CABLE. IMPEDANCE ON THE PROGRAMMER ANALYZER WAS >4000OHMS. THE PROCEDURE WAS COMPLETED USING OTHER CABLES. THE CABLE WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12895338 ↗
• MalfunctionNov 30, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO MEASURE SIGNALS FROM THE LEAD WITH THE ANALYZER SURGICAL CABLE. IMPEDANCE ON THE PROGRAMMER ANALYZER WAS >4000 OHMS. THE PROCEDURE WAS COMPLETED USING OTHER CABLES. THE CABLE WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12895330 ↗
• MalfunctionNov 30, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO MEASURE SIGNALS FROM THE LEAD WITH THE ANALYZER SURGICAL CABLE. IMPEDANCE ON THE PROGRAMMER ANALYZER WAS >4000 OHMS. THE PROCEDURE WAS COMPLETED USING OTHER CABLES. THE CABLE WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12895243 ↗
• MalfunctionNov 30, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO MEASURE SIGNALS FROM THE LEAD WITH THE ANALYZER SURGICAL CABLE. IMPEDANCE ON THE PROGRAMMER ANALYZER WAS >4000 OHMS. THE PROCEDURE WAS COMPLETED USING OTHER CABLES. THE CABLE WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12895152 ↗
• MalfunctionNov 30, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO MEASURE SIGNALS FROM THE LEAD WITH THE ANALYZER SURGICAL CABLE. IMPEDANCE ON THE PROGRAMMER ANALYZER WAS >4000OHMS. THE PROCEDURE WAS COMPLETED USING OTHER CABLES. THE CABLE WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12895133 ↗
• MalfunctionNov 30, 2021Impedance Problem; Material Integrity Problem; Impedance Problem; Material Integrity Problem

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO MEASURE SIGNALS FROM THE LEAD WITH THE ANALYZER SURGICAL CABLE. IMPEDANCE ON THE PROGRAMMER ANALYZER WAS >4000OHMS. THE PROCEDURE WAS COMPLETED USING OTHER CABLES. THE CABLE WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12895076 ↗
• MalfunctionJan 16, 2019Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  THE CABLES WERE RETURNED FOR ANALYSIS.

  Patient problems: No Patient Involvement

  MAUDE report 8255155 ↗

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-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-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-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-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-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-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