NA 2067 (UDI 00613994362896)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00613994362896), received between Apr 10, 2018 and Aug 30, 2026 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (10 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2026Electrical Shorting

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50513034 ↗
• MalfunctionApr 13, 2026Unexpected Shutdown

  THE RADIOFREQUENCY (RF) HEAD 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 24854350 ↗
• MalfunctionAug 11, 2025Unexpected Shutdown; Unexpected Shutdown

  THE RADIOFREQUENCY (RF) HEAD 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 22769019 ↗
• MalfunctionMay 20, 2025Electrical Shorting; Electrical Shorting

  IT WAS REPORTED THAT THE RADIOFREQUENCY(RF) HEAD HAD A SHORT CIRCUIT THAT CAUSED THE PROGRAMMER TO SHUT DOWN. IT WAS NOTED THAT THE PROGRAMMER FUNCTIONED NORMALLY WHEN RF HEAD IS DISCONNECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050661 ↗
• MalfunctionMay 7, 2025Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PROGRAMMER SHUT DOWN SPONTANEOUSLY AFTER CONNECTING THE RADIOFREQUENCY (RF) HEAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21974861 ↗
• MalfunctionMar 3, 2025Unexpected Shutdown; Unexpected Shutdown

  THE RADIOFREQUENCY (RF) HEAD 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 21501989 ↗
• MalfunctionDec 2, 2024Electrical Shorting; Material Integrity Problem; Electrical Shorting; Material Integrity Problem

  IT WAS REPORTED THAT WHENEVER THE RADIOFREQUENCY (RF) HEAD WAS SLIGHTLY MOVED, IT CAUSED A SHORT-CIRCUIT TO THE PROGRAMMER, RESULTED IN SUDDEN POWER OFF/SHUTDOWN. THE RF HEAD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20818737 ↗
• MalfunctionNov 13, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS FURTHER REPORTED THAT THE RADIOFREQUENCY (RF) HEAD WAS RETURNED FOR EVALUATION AS AN ASSOCIATE PRODUCT AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20672562 ↗
• MalfunctionAug 14, 2024Unexpected Shutdown; Unexpected Shutdown

  THE RADIOFREQUENCY (RF) HEAD 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 19979214 ↗
• MalfunctionApr 8, 2024Communication or Transmission Problem; Unexpected Shutdown; Communication or Transmission Problem; Unexpected Shutdown

  IT WAS REPORTED THAT THE RADIOFREQUENCY (RF) HEAD WAS UNABLE TO INTERROGATE. THE RF HEAD HAS BEEN RETURNED FOR EVALUATION AND SUBSEQ UENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19058142 ↗
• MalfunctionMay 8, 2023Corroded; Use of Device Problem; Corroded; Use of Device Problem

  IT WAS REPORTED THAT THE RADIOFREQUENCY (RF) HEAD WAS NOT WORKING. THE RF HEAD WAS RETURNED FOR EVALUATION AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16884411 ↗
• MalfunctionNov 24, 2022Electrical /Electronic Property Problem; Communication or Transmission Problem; Electrical /Electronic Property Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE RADIOFREQUENCY (RF) HEAD HAD AN INTERROGATION ISSUE. IT WAS FURTHER REPORTED THAT THE RF HEAD SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15859950 ↗
• MalfunctionNov 15, 2022Break; Material Integrity Problem; Unexpected Shutdown; Break; Material Integrity Problem; Unexpected Shutdown

  IT WAS REPORTED THAT THE CABLE INSULATION OF THE RADIOFREQUENCY (RF) HEAD WAS BROKEN. THE RF HEAD WAS RETURNED TO SERVICE 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 15796341 ↗
• MalfunctionSep 19, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE RADIOFREQUENCY HEAD WHICH WAS RETURNED AS AN ASSOCIATE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ASS ESSMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15444727 ↗
• MalfunctionJul 7, 2022Corroded; Corroded

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14943037 ↗
• MalfunctionMar 1, 2021Use of Device Problem; Communication or Transmission Problem; Use of Device Problem; Communication or Transmission Problem

  IT WAS FURTHER REPORTED THROUGH FOLLOW UP THAT THE RADIOFREQUENCY PROGRAMMING HEAD WAS USED TO INTERROGATE A DEVICE PRIOR TO IMPLANT AND WOULD NOT ESTABLISH CONSISTENT COMMUNICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391493 ↗
• MalfunctionFeb 2, 2021Electrical Shorting; Material Integrity Problem; Electrical Shorting; Material Integrity Problem

  IT WAS REPORTED THAT THE RADIO FREQUENCY (RF) PROGRAMMER HEAD WIRES WERE BEGINNING TO SHORT. THE RF HEAD 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 11264874 ↗
• MalfunctionJan 12, 2021Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT WHEN THE PROGRAMMER IS POWERED ON, THE SCREEN DOES NOT TURN ON. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT. THE PROGRAMMER SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. THE RADIOFREQUENCY PROGRAMMER HEAD ORIGINALLY RETURNED AS AN ASSOCIATED DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11154402 ↗
• MalfunctionJan 8, 2021Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT WHEN THE PROGRAMMER HEAD CONNECTOR WAS MOVED, THE PROGRAMMER TURNED OFF. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDING CARRYING OUT SEVERAL TESTS WHICH GAVE THE SAME RESULTS. THERE WAS NO PATIENT INVOLVEMENT. IT WAS FURTHER REPORTED THAT THE RADIOFREQUENCY PROGRAMMER HEAD ORIGINALLY RETURNED AS AN ASSOCIATED DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11138528 ↗
• MalfunctionDec 22, 2020Moisture Damage; Moisture Damage

  IT WAS REPORTED THAT THE RADIOFREQUENCY PROGRAMMER HEAD ORIGINALLY RETURNED AS AN ASSOCIATED DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11054203 ↗
• MalfunctionOct 23, 2020Material Integrity Problem; Material Integrity Problem

  THE RADIOFREQUENCY HEAD (RF HEAD) RETURNED WITH THE PROGRAMMER AS A ASSOCIATED DEVICE TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10725916 ↗
• MalfunctionOct 23, 2020Material Integrity Problem; Material Integrity Problem

  THE RADIO FREQUENCY (RF) PROGRAMMER HEAD WAS RETURNED AS AN ASSOCIATED DEVICE AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURERS ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10725251 ↗
• MalfunctionOct 13, 2020Computer Operating System Problem; Computer Operating System Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 10670160 ↗
• MalfunctionOct 8, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PROGRAMMER BLACKED OUT, AND SHUT DOWN DURING A SOFTWARE UPDATE ALONG WITH A CRACKLING NOISE RESULTING IN THE PROGRAMMER BEING IMPOSSIBLE TO UPDATE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10648361 ↗
• MalfunctionSep 22, 2020Electrical Shorting; Electrical Shorting

  IT WAS REPORTED THAT AFTER THE "PROGRAM CONTROL HEAD" (RADIOFREQUENCY HEAD) WAS PLUGGED IN, THE "PROGRAM CONTROLLER" (PROGRAMMER) AUTOMATICALLY POWERED OFF. IT WAS NOTED THAT THE ISSUE OCCURRED DURING SET UP. THE RADIOFREQUENCY HEAD HAS BEEN RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10567100 ↗

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-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-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-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-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