NA 229047Recalls & reported problems

Summary

The FDA's MAUDE database contains 662 adverse event reports that list this exact device (DI 00721902256011), received between Apr 6, 2017 and Sep 30, 2026 — classified as 24 injuries, 638 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (198 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jan 17, 2019Terminated

   There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its Recommended Replacement Time (RRT).

   Z-0795-2019 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 662 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Communication or Transmission Problem

  The analyzer was returned for evaluation as an associated product and was subsequently tested out of specification during the manufacturer's analysis. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945254 ↗
• MalfunctionSep 1, 2026Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50547253 ↗
• MalfunctionSep 1, 2026Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50539711 ↗
• MalfunctionJun 25, 2026Contamination

  IT WAS FURTHER REPORTED THAT THE ANALYZER ORIGINALLY RETURNED AS AN ASSOCIATED INSTRUMENT SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25616997 ↗
• MalfunctionJun 23, 2026Use of Device Problem

  THE ANALYZER WAS RETURNED FOR EVALUATION AS AN ASSOCIATE PRODUCT AND WAS SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING THE MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25591433 ↗
• MalfunctionApr 24, 2026Connection Problem

  IT WAS REPORTED THAT THE ANALYZER CONNECTOR HAD POOR CONTACT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24976595 ↗
• MalfunctionApr 13, 2026Electrical /Electronic Property Problem

  THE ANALYZER WAS RETURNED FOR EVALUATION AS AN ASSOCIATE PRODUCT AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24857166 ↗
• MalfunctionApr 7, 2026Pacing Problem

  THE ANLYZER WAS RETURNED FOR EVALUATION AS AN ASSOCIATE PRODUCT AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801251 ↗
• MalfunctionApr 7, 2026Inadequate User Interface

  IT WAS REPORTED THAT THE PROGRAMMER'S SCREEN DISPLAYED A "CONNECTION FAILED" MESSAGE WHEN SWITCHING TO THE ANALYZER. IT WAS ALSO REPORTED THAT THE CONNECTION OF THE ANALYZER WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800143 ↗
• MalfunctionApr 5, 2026Electrical /Electronic Property Problem

  THE ANALYZER WAS RETURNED FOR EVALUATION AS AN ASSOCIATE PRODUCT AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24786775 ↗
• MalfunctionMar 24, 2026Impedance Problem

  THE ANALYZER WAS RETURNED AS PART OF AN INVENTORY REDUCTION INITIATIVE AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING THE MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24672351 ↗
• MalfunctionMar 4, 2026Electrical /Electronic Property Problem

  THE ANALYZER WAS RETURNED AS PART OF AN INVENTORY REDUCTION INITIATIVE AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24511647 ↗
• MalfunctionFeb 26, 2026Electrical /Electronic Property Problem

  THE ANALYZER WAS RETURNED FOR EVALUATION AS AN ASSOCIATE PRODUCT AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24465814 ↗
• MalfunctionFeb 9, 2026Computer Software Problem; Failure to Power Up; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED AN ERROR MESSAGE INDICATING ¿UNABLE TO CONNECT TO THE ANALYZER¿ EVEN AFTER BEING SCREWED IN TIGHTLY. IT WAS NOTED THAT THE PROGRAMMER WAS ABLE TO CONNECT AND FUNCTIONED PROPERLY WITH THE NEW ANALYZER. THE ANALYZER HAS BEEN RETURNED FOR EVALUATION AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288713 ↗
• MalfunctionJan 22, 2026Battery Problem

  IT WAS REPORTED THAT THE ANALYZER REPORTED A LOW BATTERY EVEN WITH A NEW BATTERY, EVER SINCE BATTERY LEAKAGE CAUSED CORROSION ON THE TERMINAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24158219 ↗
• MalfunctionJan 21, 2026Electrical /Electronic Property Problem

  ANALYZER WAS RETURNED FOR EVALUATION AS AN ASSOCIATE PRODUCT AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141377 ↗
• MalfunctionJan 21, 2026Electrical /Electronic Property Problem

  THE ANALYZER WAS RETURNED FOR EVALUATION AS AN ASSOCIATE PRODUCT AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128529 ↗
• MalfunctionJan 20, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT THE ANALYZER HAD A LOOSE CONNECTOR, MAKING IT UNABLE TO PROVIDE RELIABLE TESTING VALUES FROM THE RIGHT VENTRICULAR CHANNEL DURING LEAD TESTING AT THE TIME OF PACEMAKER IMPLANTATION. TROUBLESHOOTING STEPS WERE TAKEN TO USE MULTIPLE DIFFERENT ANALYZER CABLES TO NO AVAIL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24112710 ↗
• MalfunctionJan 15, 2026Electrical /Electronic Property Problem

  THE ANALYZER WAS RETURNED AS AN ASSOCIATED DEVICE AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING THE MANUFACTURER¿S ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24078086 ↗
• MalfunctionJan 13, 2026Electrical /Electronic Property Problem

  THE ANALYZER WAS RETURNED AS PART OF AN INVENTORY REDUCTION INITIATIVE AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24050881 ↗
• MalfunctionJan 7, 2026Electrical Power Problem

  THE ANALYZER WAS RETURNED FOR EVALUATION AS AN ASSOCIATE PRODUCT AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23986939 ↗
• MalfunctionJan 4, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE INITIAL LEAD WAS TUNNELED AND DEPLOYED. THE LEAD WAS CONNECTED TO THE ANALYZER AND OVERSENSING WITH NOISE WAS OBSERVED. TWO SETS OF CABLES AND TWO Y-ADAPTORS. ANOTHER ANALYZER WAS BROUGHT IN AND THE SAME ISSUE WAS OBSERVED. ANOTHER LEAD WAS ATTEMPTED AND THE OVERSENSING WITH NOISE CONTINUED TO BE OBSERVED. A THIRD ANALYZER WAS USED BUT PHYSIOLOGIC NOISE WAS STILL PRESENT; OCCASIONALLY WOULD GET A REAL QRS. SINCE SENSING WAS ACCEPTABLE, THE LEAD WAS TUNNELED TO DEVICE POCKED AND CONNECTED. THROUGH THE DEVICE, AIR WAS OBSERVED AND IMPEDANCES WERE NOTED TO BE HIGH/OUT OF RANGE. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TWO PROGRAMMERS EXPERIENCED A NOISY SIGNAL, AND IT WAS NOTED THAT THE TWO PROGRAMMER ANALYZERS WERE UNABLE TO SENSE ACCURATELY DUE TO THE NOISE. THE PROGRAMMER AND ANALYZER REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23953835 ↗
• MalfunctionDec 30, 2025Defective Device; Defective Device

  THE ANALYZER WAS RETURNED FOR EVALUATION AS AN ASSOCIATE PRODUCT AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919569 ↗
• MalfunctionDec 15, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS FURTHER REPORTED THAT THE ANALYZER ORIGINALLY RETURNED AS AN ASSOCIATED INSTRUMENT SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23800226 ↗
• MalfunctionDec 3, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE ANALYZER WAS RETURNED FOR EVALUATION AS AN ASSOCIATE PRODUCT AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23701889 ↗

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-2506-2020 · Jun 4, 2020 · Open, Classified
  Patient Connector, Model Number 24967
• Z-2505-2020 · Jun 4, 2020 · Open, Classified
  CareLink SmartSync Device Manager, Model Number 24970A
• 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