NA 2292 (UDI 00643169703247)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00643169703247), received between Apr 10, 2018 and Aug 20, 2025 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionAug 20, 2025Material Integrity Problem; Output Problem; Material Integrity Problem; Output Problem

  IT WAS REPORTED THAT THE ANALYZER SURGICAL CABLE HAD PROBLEM WITH MEASUREMENTS, AND NO SIGNAL WAS DETECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22848273 ↗
• MalfunctionAug 20, 2025Material Integrity Problem; Output Problem; Material Integrity Problem; Output Problem

  IT WAS REPORTED THAT THE ANALYZER SURGICAL CABLE HAD PROBLEM WITH MEASUREMENTS, AND NO SIGNAL WAS DETECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22848266 ↗
• MalfunctionOct 24, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE VENTRICULAR CLIPS OF THE ANALYZER SURGICAL CABLES DID NOT WORK DURING PRE-OPERATIVE TESTING OF THE CABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994149 ↗
• MalfunctionOct 24, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE VENTRICULAR CLIPS OF THE ANALYZER SURGICAL CABLES DID NOT WORK DURING PRE-OPERATIVE TESTING OF THE CABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994124 ↗
• MalfunctionSep 18, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SURGICAL CABLE RIGHT ATRIAL (RA) CLIP WAS UNABLE TO FUNCTION DURING PRE-OPERATIVE TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17763175 ↗
• MalfunctionAug 24, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17610854 ↗
• MalfunctionJul 5, 2023Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE ANALYZER CABLE HAD A DIFFICULTY SENSING THE P-WAVE WITH THE RIGHT ATRIAL ALLIGATOR CLIP. THE USER CHANGED TO THE RIGHT VENTRICULAR ALLIGATOR CLIP AND IT WAS THEN POSSIBLE TO MEASURE THE P-WAVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259699 ↗
• MalfunctionJul 5, 2023Device Sensing Problem; Device Sensing Problem

  THE ANALYZER CABLE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259395 ↗
• MalfunctionJul 5, 2023Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE ANALYZER CABLE HAD A DIFFICULTY SENSING THE P-WAVE WITH THE RIGHT ATRIAL ALLIGATOR CLIP. THE USER CHANGED TO THE RIGHT VENTRICULAR ALLIGATOR CLIP AND IT WAS THEN POSSIBLE TO MEASURE THE P-WAVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17255796 ↗
• MalfunctionMar 6, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD CLIP OF THE PATIENT CABLE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485242 ↗
• MalfunctionMar 6, 2023Device Sensing Problem; Material Integrity Problem; Device Sensing Problem; Material Integrity Problem

  IT WAS FURTHER REPORTED THAT THE ANALYZER CABLE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16484883 ↗
• MalfunctionJul 7, 2022Signal Artifact/Noise; Under-Sensing; Device Sensing Problem; Material Integrity Problem; Signal Artifact/Noise; Under-Sensing; Device Sensing Problem; Material Integrity Problem

  IT WAS REPORTED THAT WHEN TAKING MEASUREMENTS THROUGH THE ANALYZER CABLE, ARTEFACTS WERE NOTED ON THE VENTRICULAR CHANNEL. IT WAS ALSO REPORTED THAT THERE WAS A VARIANCE IN THE MEASUREMENTS BETWEEN THE ATRIAL AND VENTRICULAR  CHANNEL, UNDERSENSING WAS ALSO NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14948322 ↗
• MalfunctionJul 4, 2022Signal Artifact/Noise; Sensing Intermittently; Signal Artifact/Noise; Sensing Intermittently

  IT WAS REPORTED THAT THE PROGRAMMER ANALYZER CABLE WAS UNABLE TO MEASURE THE DEVICE AND GAVE UNSTABLE VALUES DURING PROCEDURE. IT WAS NOTED THAT THE ANALYZER VENTRICULAR CABLE PRODUCED A LOT OF NOISE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14909284 ↗
• MalfunctionMar 31, 2022Impedance Problem; Material Integrity Problem; Impedance Problem; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO AN IMPLANT PROCEDURE, THE  ANALYZER SURGICAL CABLE EXHIBITED HIGH IMPEDANCE WHEN TESTING VIA A SHORT CIRCUIT. THE ANALYZER WAS REPLACED BUT HIGH IMPEDANCE VALUES WERE STILL EXHIBITED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13963427 ↗
• MalfunctionMar 31, 2022Impedance Problem; Material Integrity Problem; Impedance Problem; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO AN IMPLANT PROCEDURE, THE  ANALYZER SURGICAL CABLE EXHIBITED HIGH IMPEDANCE WHEN TESTING VIA A SHORT CIRCUIT. THE ANALYZER WAS REPLACED BUT HIGH IMPEDANCE VALUES WERE STILL EXHIBITED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13963410 ↗
• MalfunctionMar 16, 2022Material Integrity Problem; Output Problem; Material Integrity Problem; Output Problem

  IT WAS REPORTED THAT THE ANALYZER CABLE WAS UNABLE TO SCALE THE VALUES OF THE LEADS. THE CABLE 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 13786549 ↗
• MalfunctionOct 15, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO MEASURE SIGNALS FROM THE LEAD WITH THE ANALYZER SURGICAL CABLE. IMPEDANCE ON THE PROGRAMMER ANALYZER WAS >4000OHMS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12637967 ↗
• MalfunctionOct 15, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO MEASURE SIGNALS FROM THE LEAD WITH THE ANALYZER SURGICAL CABLE. IMPEDANCE ON THE PROGRAMMER ANALYZER WAS >4000OHMS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12637964 ↗
• MalfunctionOct 15, 2021Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO MEASURE SIGNALS FROM THE LEAD WITH THE ANALYZER SURGICAL CABLE. IMPEDANCE ON THE PROGRAMMER ANALYZER WAS >4000OHMS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12637957 ↗
• MalfunctionAug 27, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT WHEN PERFORMING DETECTION TESTS FOR IMPLANTED LEADS USING THE ANALYZER SURGICAL CABLE WITH THE PROGRAMMER IT WAS OBSERVED THAT WHEN CONNECTING ONLY THE ATRIUM PINS (BLUE PINS) IN THE LEAD, THE PROGRAMMER SHOWED THE DETECTION VALUE IN THE VENTRICLE SECTION AND WHEN CONNECTING ONLY THE VENTRICLE PINS (WHITE PINS) IN THE LEAD, THE PROGRAMMER SHOWED THE DETECTION VALUE IN THE ATRIUM SECTION. IT WAS NOTED THAT THE ANALYZER SURGICAL CABLE WAS SWITCHED OUT FOR A DIFFERENT CABLE WHICH RESOLVED THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12376599 ↗
• MalfunctionMar 25, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ONE OF THE ALLIGATOR CLIPS OF THE ANALYZER SURGICAL CABLE WAS ALMOST DETACHED FROM THE CABLE AFTER LESS THAN 5 RE-STERILIZATIONS. IT WAS NOTED THAT THE CABLE WAS HANDLED NORMALLY AT THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11567719 ↗
• MalfunctionAug 29, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ANALYZER SURGICAL CABLE HAD NO DETECTION OR STIMULATION AND WOULD NOT MAKE LEAD MEASUREMENTS. THE STATUS OF THE CABLE IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7826934 ↗
• MalfunctionJul 10, 2018Signal Artifact/Noise; Material Integrity Problem; Noise, Audible; Signal Artifact/Noise; Material Integrity Problem

  IT WAS REPORTED THAT THE ANALYZER CABLES SHOWED NOISE ON THE VENTRICULAR CHANNEL AFTER STERILIZATION. THE CABLE WAS RETURNED FOR ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7673875 ↗
• InjuryJun 14, 2018Failure to Capture; Failure to Capture

  IT WAS FURTHER REPORTED THAT THE CABLES WERE RETURNED TO SERVICE.

  Patient problems: Arrhythmia; Seizures

  MAUDE report 7601199 ↗
• MalfunctionApr 10, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CUSTOMER HAD MULTIPLE ANALYZER CABLES WHICH WERE NOT WORKING PROPERLY, AS THE CABLES COULD NOT BE USED TO MEASURE SIGNALS ON THE ATRIAL CHANNEL OR VENTRICULAR AND/OR HAD NOISE ON THE ATRIAL OR VENTRICULAR CHANNEL. THE CABLES WERE RETURNED FOR ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7415709 ↗

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