NA 2067 (UDI 00721902290121)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00721902290121), received between Jun 8, 2017 and Feb 15, 2022 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Electrical Shorting” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2022Electrical Shorting; Electrical Shorting

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13531923 ↗
• 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 11264834 ↗
• MalfunctionNov 20, 2020Electrical Shorting; Electrical Shorting

  IT WAS REPORTED THAT THE RADIOFREQUENCY (RF) HEAD WAS SHORTING OUT THE PROGRAMMER. IT WAS NOTED THAT THE RF HEAD WAS RECENTLY RETURNED FROM SERVICE AND THE USER WAS TROUBLESHOOTING. IT WAS SUGGESTED THAT THE ISSUE WAS THE RF HEAD, WHEN THE HEAD WAS REMOVED THE PROGRAMMER BOOTED UP. THE PROGRAMMER REMAINS IN USE. THE RF HEAD WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10874576 ↗
• MalfunctionOct 20, 2020Unexpected Shutdown; Unexpected Shutdown

  IT WAS FURTHER 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 Patient Involvement

  MAUDE report 10703813 ↗
• MalfunctionJul 16, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE RADIO FREQUENCY PROGRAMMING HEAD (RF HEAD) HAD A TELEMETRY ISSUE AND COULD NOT READ SMOOTHLY. THE RF HEAD WAS RECEIVED INTO SERVICE. THERE WAS NO PATIENT INVOLVEMENT. IT WAS FURTHER REPORTED THAT THE RF HEAD TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.

  Patient problems: No Patient Involvement

  MAUDE report 10281583 ↗
• MalfunctionApr 28, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS FURTHER REPORTED THAT THE RADIO FREQUENCY (RF) HEAD CABLE TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10004990 ↗
• MalfunctionFeb 20, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE RADIO FREQUENCY (RF) PROGRAMMING HEAD WAS RETURNED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9733915 ↗
• MalfunctionFeb 18, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  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 Patient Involvement

  MAUDE report 9722968 ↗
• MalfunctionNov 4, 2019Electrical Shorting; Electrical Shorting

  IT WAS REPORTED THAT THE RADIOFREQUENCY (RF) HEAD HAD A SHORT, AND THE PROGRAMMER TELEMETRY WOULD CUT OUT WHEN INTERROGATING A DEVICE. THE RF HEAD WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9271798 ↗
• MalfunctionSep 12, 2019Contamination; Electrical /Electronic Property Problem; Contamination; Electrical /Electronic Property Problem

  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 Patient Involvement

  MAUDE report 9008163 ↗
• MalfunctionSep 23, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS 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 7900698 ↗
• MalfunctionAug 7, 2018Application Program Problem; Communication or Transmission Problem; Electrical Shorting; Communication or Transmission Problem; Electrical Shorting

  IT WAS REPORTED THAT THE RADIOFREQUENCY PROGRAMMER HEAD WAS INTERMITTENTLY UNABLE TO GET ANY GREEN LIGHTS AND THIS WAS ATTRIBUTED TO A POSSIBLE SHORT IN ITS CABLE. THE HEAD WAS 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 7758683 ↗
• MalfunctionJun 4, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT SOON AFTER POWERING THE PROGRAMMER ON IT AUTOMATICALLY TURNED OFF. THE PROGRAMMER WAS CHANGED OUT AND RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. 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 7567538 ↗
• MalfunctionMay 16, 2018Material Integrity Problem; Material Integrity Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 7518553 ↗
• MalfunctionDec 8, 2017Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE RADIOFREQUENCY HEAD WAS UNABLE TO LIGHT GREEN AND WAS UNABLE TO INTERROGATE DEVICES. THE RADIOFREQUENCY HEAD WAS 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 7101685 ↗
• MalfunctionJun 8, 2017Electrical Shorting; Electrical Shorting

  IT WAS REPORTED WHEN THE PROGRAMMER WAS TURNED ON NOTHING HAPPENED, BLACK SCREEN. THE RF (RADIO FREQUENCY) HEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6625919 ↗

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-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