NA 2067L (UDI 00613994435125)Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00613994435125), received between Dec 9, 2016 and Aug 12, 2026 — classified as 1 injury, 44 malfunctions.

The most frequently reported specific device problem is “Corroded” (14 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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Electrical Shorting

  The Radiofrequency (RF) head was returned for evaluation as an associated device 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 50219815 ↗
• MalfunctionNov 27, 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 20795245 ↗
• MalfunctionFeb 13, 2024Corroded; Corroded

  IT WAS REPORTED THAT THE RADIOFREQUENCY (RF) HEAD WAS BROKEN. THE RF HEAD WAS 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 18693708 ↗
• MalfunctionJan 11, 2024Contamination; Contamination

  IT WAS REPORTED THAT THE RADIO FREQUENCY (RF) HEAD WHICH WAS RETURNED FOR EVALUATION SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490881 ↗
• MalfunctionNov 16, 2023Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT THE HEAD COVER OF THE RADIOFREQUENCY (RF) HEAD WAS BROKEN. THE RF HEAD 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 18146401 ↗
• MalfunctionAug 24, 2023Material Integrity Problem; Power Problem; Material Integrity Problem; Power Problem

  IT WAS REPORTED THAT THE PROGRAMMER WOULD REBOOT WITHOUT PROMPT WHEN THE RADIOFREQUENCY (RF) HEAD AND ITS CORD WERE MOVED. THE RF HEAD RETURNED FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17611796 ↗
• MalfunctionMar 14, 2023Corroded; Corroded

  IT WAS REPORTED THAT THE PROGRAMMER AND THE RADIOFREQUENCY (RF) HEAD WERE 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 16536610 ↗
• MalfunctionJun 9, 2022Electrical Shorting; Electrical Shorting

  THE RADIOFREQUENCY HEAD WHICH WAS RETURNED AS AN ASSOCIATE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ASSESSMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14641682 ↗
• MalfunctionMay 13, 2022Electrical Shorting; Electrical Shorting

  IT WAS REPORTED THAT THE RADIOFREQUENCY (RF) HEAD EXPERIENCED A POTENTIAL ELECTRICAL SHORT. IT WAS NOTED THAT NO LIGHTS WERE DISPLAYING ON THE RF HEAD. IT WAS ALSO NOTED THAT THE PROGRAMMER EXPERIENCED TELEMETRY ISSUES. THE RF HEAD AND PROGRAMMER HAVE BEEN RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14396778 ↗
• MalfunctionFeb 14, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE RADIOFREQUENCY (RF) HEAD WHICH WAS RETURNED AS NO LONGER REQUIRED SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13522044 ↗
• MalfunctionNov 11, 2021Electrical Shorting; Unexpected Shutdown; Electrical Shorting; Unexpected Shutdown

  IT WAS REPORTED THAT THE RADIOFREQUENCY HEAD WAS SHORT CIRCUITED AND WHEN CONNECTED TO A PROGRAMMER WOULD CAUSE THE PROGRAMMER TO SHUT DOWN IN THE MAGNETIC RESONANCE IMAGING (MRI) ROOM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12795856 ↗
• MalfunctionNov 1, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS A "SHORT" IN THE CABLE OF THE RADIOFREQUENCY (RF) HEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12727155 ↗
• MalfunctionOct 6, 2021Corroded; Corroded

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12582977 ↗
• MalfunctionMay 5, 2021Corroded; Corroded

  IT WAS REPORTED THAT THE RADIOFREQUENCY (RF) HEAD WHICH WAS RETURNED AS AN ASSOCIATE DEVICE TESTED OUT OF SPECIFICATION DURING MANUFACTURERS ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11775825 ↗
• MalfunctionApr 16, 2021Corroded; Corroded

  IT WAS REPORTED THAT THE RADIOFREQUENCY HEAD ORIGINALLY RETURNED WITH THE PROGRAMMER 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 11678046 ↗
• MalfunctionMar 18, 2021Corroded; Corroded

  IT WAS REPORTED THAT THE RADIOFREQUENCY HEAD (RF HEAD) RETURNED INTO SERVICE WITH THE PROGRAMMER 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 11511257 ↗
• MalfunctionMar 15, 2021Corroded; Corroded

  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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11480256 ↗
• MalfunctionFeb 11, 2021Corroded; 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 11312550 ↗
• MalfunctionJan 28, 2021Defective Component; Unexpected Shutdown; Defective Component; Unexpected Shutdown

  IT WAS REPORTED THAT THE RADIOFREQUENCY (RF) HEAD ORIGINALLY RETURNED AS AN ASSOCIATED DEVICE 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 11242387 ↗
• MalfunctionDec 17, 2020Corroded; Corroded

  THE RADIO FREQUENCY (RF) PROGRAMMER HEAD WAS RETURNED AS IT WAS NO LONGER NEEDED 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 11026310 ↗
• MalfunctionAug 24, 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 10441189 ↗
• MalfunctionAug 20, 2020Device Contamination with Body Fluid; Device Contamination with Body Fluid

  THE RADIOFREQUENCY HEAD WAS RETURNED AS AN ASSOCIATE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURERS ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10430007 ↗
• InjuryJul 28, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THE PATIENT IS PACEMAKER DEPENDENT, DURING THE PROCEDURE WHILST USING THE ANALYSERS SURGICAL CABLE, TRANSMISSION WAS LOST BETWEEN THE ANALYSER AND THE IMPLANTED ELECTRODE. THERE WAS A SUDDEN LOSS OF STIMULATION, NO PEAKS WERE VISIBLE ON THE MONITOR, CONNECTION AND THE LEAD POSITION WAS CHECKED, CARDIAC MASSAGE DURING ASYSTOLE WAS REQUIRED. AFTER CHANGE TO ANOTHER PROGRAMMER AND ANOTHER MEASURING CABLE REGULAR STIMULATION TOOK PLACE AGAIN. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. IT WAS FURTHER REPORTED THE PROGRAMMER WAS USED THE FOLLOWING DAY WITH NO ISSUES REPORTED. HOSPITALISATION AND INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. THE PROGRAMMER WILL BE RETURNED FOR SERVICE TO BE TESTED WITH THE CABLE. INJURY REPORTED.

  Patient problems: Cardiac Arrest; Injury

  MAUDE report 10332964 ↗
• MalfunctionJun 22, 2020Contamination; Contamination

  IT WAS REPORTED THAT THE RADIO FREQUENCY PROGRAMMING HEAD RECEIVED INTO SERVICE WITH NO INFORMATION AND TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10178238 ↗
• MalfunctionFeb 18, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE RADIOFREQUENCY (RF) HEAD WAS RETURNED WITH NO INFORMATION AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9723475 ↗

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-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