NA 2067L (UDI 00721902290138)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00721902290138), received between Apr 10, 2018 and Aug 15, 2024 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Corroded” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2024Corroded; Corroded

  IT WAS REPORTED THAT THE PROGRAMMER TURNED ITSELF OFF AFTER POWERING ON. 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. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991161 ↗
• MalfunctionApr 28, 2023Corroded; Use of Device Problem; Corroded; Use of Device Problem

  IT WAS REPORTED THAT THE RADIOFREQUENCY (RF) HEAD WAS UNABLE TO WORK. THE RF HEAD HAS BEEN 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 16830151 ↗
• MalfunctionMay 17, 2022Corroded; Corroded

  THE RADIO FREQUENCY HEAD WAS 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 14426274 ↗
• MalfunctionMar 9, 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. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13705747 ↗
• MalfunctionDec 20, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED A BLACK SCREEN WHEN ATTEMPTING TO INTERROGATE THE PACEMAKER. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS FURTHER REPORTED THAT THE PROGRAMMER RADIOFREQUENCY 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 13042425 ↗
• MalfunctionJan 21, 2021Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE RADIOFREQUENCY PROGRAMMER HEAD ORIGINALLY RETURNED AS AN ASSOCIATED DEVICE 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 11207155 ↗
• MalfunctionJan 19, 2021Corroded; Moisture Damage; Corroded; Moisture Damage

  IT WAS REPORTED THAT THE RADIOFREQUENCY PROGRAMMER HEAD ORIGINALLY RETURNED FOR SERVICE WITH NO INFORMATION 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 11192861 ↗
• MalfunctionMay 25, 2020Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING MAINTENANCE CHECK IT WAS IDENTIFIED THAT THE PROGRAMMER TURNS OFF. THE PROGRAMMER WAS RETURNED FOR ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT. THE RF HEAD WAS RETURNED AS PART OF AN ASSOCIATED DEVICE AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.

  Patient problems: No Patient Involvement

  MAUDE report 10085107 ↗
• MalfunctionOct 30, 2019Electrical Shorting; Electrical Shorting

  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 9257463 ↗
• MalfunctionOct 14, 2019Electrical Shorting; Electrical Shorting

  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 9187695 ↗
• MalfunctionJan 17, 2019Contamination; Contamination

  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 8258942 ↗
• MalfunctionNov 15, 2018Complete Loss of Power; Complete Loss of Power

  THE RADIO FREQUENCY (RF) PROGRAMMER HEAD WAS RETURNED FOR INSPECTION, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8074715 ↗
• MalfunctionSep 3, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE RADIOFREQUENCY (RF) HEAD THAT WAS RETURNED AFTER BEING DROPPED SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7840510 ↗
• InjuryApr 10, 2018Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT AT THE END OF A VENTRICULAR THRESHOLD TEST, THE PROGRAMMER'S STYLUS PEN WAS LIFTED OFF THE SCREEN BUT INSTEAD OF IMMEDIATELY RETURNING TO PROGRAMMED PARAMETERS, THE TESTING PARAMETERS REMAINED FOR SEVERAL SECONDS CAUSING EXTENDED LOSS OF CAPTURE. THE PATIENT BECAME SYMPTOMATIC AND LIGHTHEADED AND WAS STEADIED AS THE PROGRAMMED OUTPUTS RESUMED. IT WAS INDICATED THAT IT WAS A PROBABILITY THAT THE TELEMETRY LINK BETWEEN THE RADIOFREQUENCY HEAD AND THE DEVICE WAS INTERRUPTED AND THE END COMMAND FOR THE THRESHOLD TEST WAS DELAYED. THE PROGRAMMER AND RADIOFREQUENCY HEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 7417276 ↗

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-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-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