NA 2292 (UDI 00763000181185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00763000181185), received between Feb 23, 2024 and Sep 27, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (25 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.

• MalfunctionSep 27, 2026Connection Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910095 ↗
• MalfunctionSep 27, 2026Connection Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910094 ↗
• MalfunctionJun 19, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE ANALYZER SURGICAL CABLE'S PLASTIC PROTECTIVE SLEEVES WOULD NOT PULL BACK FOR CLEANING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25561167 ↗
• MalfunctionJun 19, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE ANALYZER SURGICAL CABLE'S PLASTIC PROTECTIVE SLEEVES WOULD NOT PULL BACK FOR CLEANING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25561140 ↗
• MalfunctionJun 19, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE ANALYZER SURGICAL CABLE'S PLASTIC PROTECTIVE SLEEVES WOULD NOT PULL BACK FOR CLEANING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25561128 ↗
• MalfunctionJun 19, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE ANALYZER SURGICAL CABLE'S PLASTIC PROTECTIVE SLEEVES WOULD NOT PULL BACK FOR CLEANING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25561111 ↗
• MalfunctionJun 19, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE ANALYZER SURGICAL CABLE'S PLASTIC PROTECTIVE SLEEVES WOULD NOT PULL BACK FOR CLEANING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25561073 ↗
• MalfunctionJun 17, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE ANALYZER SURGICAL CABLE'S PLASTIC PROTECTIVE SLEEVES WOULD NOT PULL BACK FOR CLEANING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25531238 ↗
• MalfunctionJun 5, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE ANALYZER CABLE COULD NOT CONNECT TO THE MOBILE PROGRAMMER BASE. IT WAS OBSERVED THAT THE PINS WERE DEFORMED. IT WAS POSSIBLE TO CONNECT THE CABLE TO AN ALTERNATIVE PROGRAMMER ALTHOUGH ONE OF THE PINS WERE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25404673 ↗
• MalfunctionApr 6, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE ANALYZER CABLE CLIPS WERE UNABLE TO CLOSE; THEREFORE, LEAD FIXATION WAS NOT POSSIBLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787895 ↗
• MalfunctionMar 11, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE CALIPERS IN THE ANALYZER SURGICAL CABLE, AFTER BEING OPENED AND CLOSED SEVERAL TIMES, REMAINED PARTIALLY OPEN, APPROXIMATELY 30 PERCENT, AND WERE UNABLE TO ATTACH PROPERLY TO THE LEADS. AS A RESULT, THE CABLE DID NOT MAINTAIN SECURE CONTACT WITH THE LEAD DURING SURGERY. TROUBLESHOOTING STEPS WERE TAKEN INCLUDING REPLACEMENT OF CABLE AND ISSUE WAS RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566920 ↗
• MalfunctionJan 13, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE ANALYZER SURGICAL CABLE BROKE. IT WAS NOTED THAT THERE WAS A DIFFICULTY WHEN INSERTING THE CABLE INTO THE MOBILE PROGRAMMER ANALYZER PORT IN COMPARISON TO THE LEGACY PROGRAMMER. IT WAS ALSO REPORTED THAT THERE WAS A DIFFICULTY VISUALIZING THE ELECTROGRAMS (EGM) SIGNAL ON THE MOBILE PROGRAMMER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24051755 ↗
• MalfunctionJan 13, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE ANALYZER SURGICAL CABLE BROKE. IT WAS NOTED THAT THERE WAS A DIFFICULTY WHEN INSERTING THE CABLE INTO THE MOBILE PROGRAMMER ANALYZER PORT IN COMPARISON TO THE LEGACY PROGRAMMER. IT WAS ALSO REPORTED THAT THERE WAS A DIFFICULTY VISUALIZING THE ELECTROGRAMS (EGM) SIGNAL ON THE MOBILE PROGRAMMER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24051751 ↗
• MalfunctionNov 24, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SURGICAL CABLE WAS UNRESPONSIVE DURING MEASUREMENT. IT WAS NOTED THAT THE SURGICAL CABLE HAS REPLACED TO AN OTHER SURGICAL CABLE TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23628313 ↗
• MalfunctionNov 13, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ANALYZER CABLES WERE UNABLE TO FUNCTION NORMALLY AND EXHIBITED HIGH IMPEDANCE WHEN THE ANALYZER CLIPS WERE CLIPPED TOGETHER AND TESTED. IT WAS NOTED THAT THE IMPEDANCE READING WAS OVER 3000 OHMS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23540110 ↗
• MalfunctionNov 13, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ANALYZER CABLES WERE UNABLE TO FUNCTION NORMALLY AND EXHIBITED HIGH IMPEDANCE WHEN THE ANALYZER CLIPS WERE CLIPPED TOGETHER AND TESTED. IT WAS NOTED THAT THE IMPEDANCE READING WAS OVER 3000 OHMS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23540104 ↗
• 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 22848242 ↗
• MalfunctionApr 25, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ANALYZER SURGICAL CABLE'S INNER PINS WERE DAMAGED, AND THE ELECTRICAL CONTACT WAS NOT SATISFACTORY WHEN THE CABLE WAS CONNECTED TO THE ANALYZER UNIT. IT WAS NOTED THAT THE CABLE WAS USED ONLY TWO TIMES. THE USER EXPRESSED DISSATISFACTION REGARDING THE QUALITY OF THE CABLES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909179 ↗
• MalfunctionNov 15, 2024Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ANALYZER SURGICAL CABLE WAS DEFECTIVE AND WHEN HOOKED UP TO THE INSTRUMENT AND THE PATIENT, IT WAS UNABLE TO WORK. IT WAS NOTED THAT THE PROBE WAS UNABLE TO BE USED TO VERIFY IF IT WAS PLACED IN THE CORRECT LOCATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20692869 ↗
• MalfunctionAug 9, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN IMPLANTABLE PULSE GENERATOR (IPG) IMPLANT PROCEDURE IT WAS NOT POSSIBLE TO MEASURE R WAVE SENSING WITH THE ANALYZER SURGICAL CABLE. IT WAS ALSO REPORTED THAT PACING WAS NOT POSSIBLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19947541 ↗
• MalfunctionJun 21, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS FURTHER CLARIFIED THAT THE ANALYZER SURGICAL CABLE WAS UNABLE TO TAKE MEASUREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581915 ↗
• MalfunctionJun 21, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ANALYZER SURGICAL CABLE WAS DEFECTIVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581910 ↗
• MalfunctionJun 21, 2024Material Integrity Problem; Output Problem; Material Integrity Problem; Output Problem

  IT WAS REPORTED THAT THE PATIENT CABLE WAS UNABLE TO TAKE MEASUREMENTS. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE SWAPPING THE MOBILE PROGRAMMER FOR AN ALTERNATIVE PROGRAMMER, HOWEVER THE ISSUE PERSISTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19580138 ↗
• MalfunctionMay 28, 2024Material Integrity Problem; Output Problem; Material Integrity Problem; Output Problem

  IT WAS REPORTED THAT NOISE WAS EXPERIENCED WHEN THE ANALYZER SURGICAL CABLE WAS CONNECTED IN AN ATTEMPT TO MEASURE THE LEAD. CHANGING OUT THE MOBILE PROGRAMMER BASE FAILED TO RESOLVE THE ISSUE. A NON-COMPANY ALTERNATIVE PROGRAMMER WAS USED TO COMPLETE MEASUREMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19404336 ↗
• MalfunctionFeb 23, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ANALYZER SURGICAL CABLE WAS UNABLE TO PROPERLY CONNECT WITH THE ANALYZER AND LOST SIGNAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18766049 ↗

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-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-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