NA R2290Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00721902710322), received between Aug 9, 2017 and Mar 9, 2026 — classified as 58 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (24 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 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 24542360 ↗
• MalfunctionDec 19, 2025Use of Device Problem; Inadequate User Interface; Use of Device Problem; Inadequate User Interface

  IT WAS REPORTED THAT THE PROGRAMMER WAS UNABLE TO RECOGNIZE ITS ANALYZER, AS IT GENERATED AN ERROR MESSAGE INDICATING ¿WARNING: LOSS OF COMMUNICATION,¿ AND THAT THE ANALYZER WAS UNABLE TO FUNCTION PROPERLY. IT WAS ALSO NOTED THAT THE POWER SUPPLY CONNECTOR DID NOT MATCH APPROPRIATELY WITH THE POWER SUPPLY CABLE, AND THE DEVICE WAS SOMETIMES UNABLE TO TURN ON AND, AT OTHER TIMES, GENERATED UNUSUAL NOISE AND WAS UNABLE TO POWER ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847533 ↗
• MalfunctionMar 24, 2025Device Sensing Problem; Impedance Problem; Device Sensing Problem; Impedance Problem

  IT WAS REPORTED THAT THE ANALYZER'S SENSING MEASUREMENTS TRENDED LOWER THAN EXPECTED AND THE LEAD IMPEDANCE MEASUREMENTS TRENDED HIGHER THAN EXPECTED DURING LEAD ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677878 ↗
• MalfunctionSep 9, 2024Break; Break

  IT WAS REPORTED THAT THE PROGRAMMER ANALYZER CONNECTOR PINS BECAME BROKEN WHILE ATTEMPTING TO CONNECT TO THE ANALYZER SOCKET. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20167237 ↗
• MalfunctionFeb 28, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PROGRAMMERS DISPLAY WAS CRACKED. IT WAS NOTED THE RADIOFREQUENCY (RF) HEAD AND ANALYZER WERE NOT WORKING. THE PROGRAMMER, RF HEAD AND ANALYZER WERE RETURNED FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18798871 ↗
• MalfunctionJan 11, 2024Signal Artifact/Noise; Use of Device Problem; Impedance Problem; Signal Artifact/Noise; Use of Device Problem; Impedance Problem

  IT WAS REPORTED THAT THE ANALYZER WAS UNABLE TO WORK CORRECTLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491900 ↗
• MalfunctionNov 21, 2023Connection Problem; Connection Problem

  IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18180728 ↗
• MalfunctionAug 17, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE ANALYZER, WHICH WAS RETURNED FOR SERVICE AS IT HAD FALLEN FROM TABLE TO FLOOR WHEN CABLE WAS CONNECTED BREAKING THE ANALYZER SOCKET PUSHING IT INSIDE THE 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 17562496 ↗
• MalfunctionJun 7, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE ANALYZER WAS RETURNED FOR PREVENTIVE MAINTENANCE AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFA CTURER¿S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080073 ↗
• MalfunctionMay 22, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE ANALYZER WAS RETURNED TO SERVICE 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 16972569 ↗
• MalfunctionMay 17, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE ANALYZER WHICH WAS RETURNED FOR EVALUATION AS AN ASSOCIATE PRODUCT 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 16944147 ↗
• MalfunctionFeb 17, 2023Electrical /Electronic Property Problem; Inadequate User Interface; Electrical /Electronic Property Problem; Inadequate User Interface

  IT WAS REPORTED THAT THE ANALYZER LOST CONTACT WITH THE PROGRAMMER DURING AN ANALYZER SESSION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16395840 ↗
• MalfunctionJan 23, 2023Computer Software Problem; Operating System Becomes Nonfunctional; Computer Software Problem; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT WHEN PREPARING FOR A PROCEDURE THE ANALYZER DISPLAYED AND ERROR MESSAGE INDICATING THAT CONNECTION HAD BEEN LOST. IN TROUBLESHOOTING THE ANALYZER WAS POWER CYCLED MULTIPLE TIMES FAILING TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16222729 ↗
• MalfunctionNov 10, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE ANALYZER WAS RETURNED TO SERVICE 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 15769233 ↗
• MalfunctionSep 17, 2022Output Problem; Output Problem

  IT WAS REPORTED THAT THE ANALYZER GAVE INCORRECT MEASUREMENTS DURING TESTING/MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15443071 ↗
• MalfunctionSep 6, 2022No Display/Image; Failure to Power Up; Use of Device Problem; No Display/Image; Failure to Power Up; Use of Device Problem

  IT WAS REPORTED THAT THE ANALYZER 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 15359738 ↗
• MalfunctionAug 25, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE ANALYZER WHICH WAS RETURNED FOR SERVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ASSE SSMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292555 ↗
• MalfunctionAug 18, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE ANALYZER WHICH WAS RETURNED WITH THE PROGRAMMER AS AN ASSOCIATED DEVICE SUBSEQUENTLY TESTED OUT-OF-SPECIFICATION DURING MANUFACTURER'S ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15248346 ↗
• MalfunctionJun 21, 2022Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT THE PROGRAMMER ANALYZER WHICH WAS RETURNED AS PART OF A PULLBACK PROJECT SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ASSESSMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14751916 ↗
• MalfunctionJun 9, 2022Use of Device Problem; Use of Device Problem

  IT WAS FURTHER REPORTED THAT THE ANALYZER RETURNED TO SERVICE AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14641370 ↗
• MalfunctionJan 17, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PROGRAMMER WAS UNABLE TO MAINTAIN TELEMETRY WITH A DEVICE. THE RADIOFREQUENCY HEAD WAS REPLACED BUT THE ISSUE REMAINED. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS FURTHER REPORTED THAT THE ANALYZER 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 13265945 ↗
• MalfunctionNov 3, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PROGRAMMER ANALYZER WHICH WAS RETURNED FOR PREVENTIVE MAINTENANCE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12743183 ↗
• MalfunctionNov 2, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT WHEN ATTEMPTING TO CONNECT TO THE ANALYZER, THE PROGRAMMER DISPLAYED AN ERROR MESSAGE. THE ANALYZER WAS RETURNED TO SERVICE 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 12737213 ↗
• MalfunctionAug 18, 2021Electrical /Electronic Property Problem; Failure to Power Up; Use of Device Problem; Electrical /Electronic Property Problem; Failure to Power Up; Use of Device Problem

  IT WAS REPORTED THAT THE ANALYZER HAD STOPPED WORKING AND WOULD NO LONGER CONNECT TO THE PROGRAMMER. A SECOND ANALYZER WAS TESTED AND WAS ABLE TO WORK WITH THE PROGRAMMER. THE ANALYZER 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 12336670 ↗
• MalfunctionAug 4, 2021Use of Device Problem; Connection Problem; Use of Device Problem; Connection Problem

  IT WAS REPORTED THAT THE PROGRAMMER ANALYZER DOES NOT WORK DUE TO A PROBLEM WITH THE ANALYZER SOCKET. THE ANALYZER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12276317 ↗

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-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