CapSure® VDD-2 5038S-58 (UDI 00681490122931)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00681490122931), received between Feb 9, 2017 and Aug 14, 2025 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2025Pacing Problem; Connection Problem; Pacing Problem; Connection Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA. IT WAS ALSO REPORTED THAT DUE TO A LOOSE PIN THE DEVICE EXHIBITED PACING FAILURE. THE PACING LEAD WAS REINSERTED INTO THE IMPLANTABLE PULSE GENERATOR (IPG) AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 22803849 ↗
• MalfunctionJun 13, 2025Electrical /Electronic Property Problem; High impedance; Electrical /Electronic Property Problem; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE RESULTING IN POLARITY SWITCH. THE 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 22204414 ↗
• InjuryOct 29, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT A LEADLESS IPG WAS PLACED APPROXIMATELY ONE MONTH LATER.

  Patient problems: Unspecified Infection

  MAUDE report 20555665 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE PATIENT VISITED THE HOSPITAL FOR A DEVICE CHECK AND EXPOSURE OF THE DEVICE BODY WAS OBSERVED FROM THE WOUND. ANTIBIOTICS WERE GIVEN. THE DEHISCENCE WOUND WAS TREATED WITH A DRESSING. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 17037103 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PARTIALLY EXPOSED DUE TO THE CHEST INFECTION HOWEVER THE SKIN WAS THIN DUE TO BEING SLIM AND THE IPG IMPLANTATION AREA WAS COMPRESSED. THE IPG WAS REMOVED AND THE LEAD WAS INACTIVATED DUE TO IT BEING BURIED IN THE POCKET. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16255367 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE IPG HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE IPG AND LEAD WERE INACTIVATED AND UPGRADED TO A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). NO INFECTION NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12406232 ↗
• InjuryOct 19, 2020High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE RV LEAD WAS CAPPED AND REPLACED BY A LEADLESS IM PLANTABLE PULSE GENERATOR (IPG). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10696056 ↗
• MalfunctionSep 3, 2020Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT VENTRICULAR CAPTURE MANAGEMENT (VCM) DID NOT FUNCTION ON THE REPLACEMENT IMPLANTABLE PULSE GENERATOR (IPG) AFTER IT WAS IMPLANTED. IT WAS FURTHER REPORTED THAT A VCM TEST DID NOT COMPLETE DUE TO PACING LEAD NOISE. THE IPG AND PACING LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10487859 ↗
• MalfunctionMar 11, 2019Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT INTERMITTENT UNDERSENSING WAS NOTED ON THE VENTRICULAR CHANNEL DURING VENTRICULAR HIGH RATE EPISODES. THE PATIENT'S RIGHT VENTRICULAR LEAD WAS CAPPED AND REPLACED DUE TO UPGRADE TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8410647 ↗
• InjuryFeb 9, 2017High impedance; Capturing Problem; Impedance Problem; High Capture Threshold; High impedance; Capturing Problem; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED GRADUALLY INCREASING AND ELEVATED IMPEDANCE AND PACING THRESHOLD MEASUREMENTS. ADDITIONALLY, A LEAD FRACTURE IS SUSPECTED. THE POLARITY OF THE LEAD WAS REPROGRAMMED TO UNIPOLAR. 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 6320080 ↗

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-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