Capsure® VDD-2 5038S-52 (UDI 00613994250155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00613994250155), received between Aug 9, 2017 and Sep 7, 2026 — classified as 9 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (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. 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50646017 ↗
• InjuryJun 10, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE PULSE GENERATOR (IPG) WAS PARTIALLY TURNED OFF DUE TO A FAULTY LEAD. THE PATIENT ALSO NOTED THAT THEIR IPG DIED. THE IPG AND RIGHT VENTRICULAR (RV) LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25455261 ↗
• MalfunctionJun 26, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT ATRIAL OVERSENSING WAS OBSERVED ON THE VDD LEAD (RIGHT VENTRICULAR (RV) LEAD WITH DUAL CHAMBER SENSING CAPABILITIES) DURING A STORED HIGH RATE ATRIAL EPISODE. THE RV 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 19612899 ↗
• MalfunctionMar 11, 2024Signal Artifact/Noise; Device Sensing Problem; Signal Artifact/Noise; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE AND AN ARTIFACT ON STORED ELECTROGRAMS (EGM) TRIGGERING DETECTIONS AND MODE SWITCH. IT WAS NOTED THAT THE P-WAVES RECENTLY INCREASED BUT WERE WITHIN AN EXPECTED RANGE, STABLE AND CONSISTENT WITH HISTORICAL VALUES. THE RA 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 18879987 ↗
• InjuryJan 5, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT LOSS OF CAPTURE WAS OBSERVED ON THE VDD LEAD (RIGHT VENTRICULAR LEAD WITH DUAL CHAMBER SENSING CAPABILITIES). THE LEAD WAS CAPPED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18449673 ↗
• InjuryOct 27, 2023Capturing Problem; High Capture Threshold; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING AND HIGH THRESHOLDS. THE RV LEAD WAS REPROGRAMMED, CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18018718 ↗
• MalfunctionFeb 24, 2022Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE VDD RIGHT VENTRICULAR (RV) LEAD EXHIBITED RIGHT ATRIAL (RA) UNDERSENSING. THE RV 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 13596001 ↗
• MalfunctionMar 24, 2021Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DYSPNEA AND PALPITATIONS. THE RIGHT VENTRICULAR (RV) LEAD (IMPLANTABLE PULSE GENERATOR (IPG) PROGRAMMED VDD) EXHIBITED ATRIAL UNDERSENSING. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Dyspnea

  MAUDE report 11561064 ↗
• MalfunctionMay 7, 2020Signal Artifact/Noise; Mechanical Problem; Low impedance; Signal Artifact/Noise; Mechanical Problem; Low impedance

  IT WAS REPORTED THAT AN ALERT WAS NOTED FOR LOW IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. POSSIBLE NOISE AND POSSIBLE INSULATION ISSUE WHERE NOTED. 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 10031982 ↗
• InjuryApr 22, 2020Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND NOISE. 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; No Known Impact Or Consequence To Patient

  MAUDE report 9984951 ↗
• MalfunctionSep 18, 2019Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE ON VENTRICULAR HIGH RATE EPISODES. 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 9080759 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED FOR AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8802007 ↗
• InjuryApr 25, 2019Failure to Capture; Fracture; High impedance; Failure to Capture; Fracture; High impedance

  IT WAS REPORTED THAT THERE WAS A POSSIBLE FRACTURE OF THE RIGHT VENTRICULAR (RV) LEAD. HIGH IMPEDANCES AND LOSS OF CAPTURE WERE ALSO NOTED ON THE RV LEAD. THE RV LEAD WAS EXPLANTED PARTIALLY, CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8548468 ↗
• InjuryFeb 5, 2019Failure to Capture; High impedance; High Capture Threshold; Failure to Capture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS, HIGH, UNDEFINED IMPEDANCE AND NON-CAPTURE AT MAXIMUM OUTPUT. THE LEAD WAS CAPPED AND REPLACED. IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED DIMINISHED P WAVES. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8306761 ↗
• InjuryAug 9, 2017Failure to Capture; Capturing Problem; Impedance Problem; Failure to Capture; Capturing Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS NOT CAPTURING. IT WAS ALSO NOTED THAT THRESHOLDS AND IMPEDANCES HAD BEEN RISING. A LEAD REPLACEMENT PROCEDURE WAS PLANNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6781045 ↗

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-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-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-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