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CAPSURE® VDD-2 5038S-52 (UDI 00643169325708)Recalls & reported problems

Medtronic, Inc. · LEAD 5038S-52 USA NO SILACURE · Class 3 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169325708), received between Jun 5, 2018 and Jun 19, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (4 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

Device problems

  • Under-Sensing4
  • Failure to Sense1
  • Over-Sensing1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 19, 2023Under-Sensing; Under-Sensing

    IT WAS REPORTED THAT THE PACING LEAD EXHIBITED INTERMITTENT ATRIAL UNDER-SENSING ON STORED ELECTROGRAMS (EGM). THE PACING LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17150336 ↗
  • InjuryJul 11, 2022Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

    IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST IMPLANT THE VDD RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING OF P WAVES AND T WAVE OVERSENSING. THE RV LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14975193 ↗
  • MalfunctionJun 25, 2019Under-Sensing; Under-Sensing

    IT WAS REPORTED THAT THE PACING LEAD EXHIBITED EVIDENCE OF ATRIAL UNDERSENSING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8730630 ↗
  • MalfunctionJun 5, 2018Failure to Sense; Under-Sensing; Failure to Sense; Under-Sensing

    IT WAS REPORTED THAT THERE WAS ATRIAL UNDERSENSING AS WELL AS NO ATRIAL SENSING SEEN ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7571009 ↗

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-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

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Sources and updates

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