CAPSURE® VDD-2 5038-58 (UDI 00643169325678)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00643169325678), received between Oct 6, 2017 and Jul 18, 2025 — classified as 10 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (12 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 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACH YCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AT TIMES. 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 22539701 ↗
• MalfunctionDec 18, 2023Under-Sensing; Under-Sensing

  IT WAS FURTHER REPORTED THAT ATRIAL UNDERSENSING OCCURRED ON THE VDD LEAD WHICH IS CHRONIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18344864 ↗
• MalfunctionJul 17, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT RIGHT ATRIAL (RA) UNDERSENSING WAS OBSERVED ON THE VDD LEAD (RIGHT VENTRICULAR LEAD WITH DUAL CHAMBER SENSING C APABILITIES). 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 17331546 ↗
• InjuryMay 18, 2022Break; Over-Sensing; Low impedance; Decreased Sensitivity; Capturing Problem; Impedance Problem; High Capture Threshold; Unstable Capture Threshold; Break; Over-Sensing; Low impedance; Decreased Sensitivity; Capturing Problem; Impedance Problem; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT LOW AND FLUCTUATING IMPEDANCE WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. RISING AND FLUCTUATING THRESHOLDS AND DECREASING R WAVES WERE ALSO NOTED. DURING THE REVISION PROCEDURE, INSULATION DAMAGE WAS NOTED. THE LEAD AND IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14427694 ↗
• InjuryMar 10, 2022Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD PORTION OF THE VDD RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. THE ATRIAL SENSE PORTION OF THE RV LEAD WAS CAPPED. A PLANNED PACING LEAD REPLACEMENT WAS OPENED AND NOT USED DUE TO PATIENT ANATOMY. THE VDD 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 13721405 ↗
• InjuryNov 26, 2021Failure to Capture; Under-Sensing; Failure to Capture; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CARDIAC ARREST (VENTRICULAR FIBRILLATION (VF)) AND BRADYCARDIA ARREST. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING AND NO CAPTURE. THE PATIENT WAS EXTERNALLY DEFIBRILLATED. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest; Ventricular Fibrillation

  MAUDE report 12877360 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12541646 ↗
• MalfunctionJun 14, 2021Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING AND POTENTIAL OVERSENSING. 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 11990255 ↗
• MalfunctionApr 27, 2021Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD, PROGRAMMED TO A NON-TRADITIONAL VDD MODE, EXHIBITED A POSSIBLE ATRIAL ARRHYTHMIA WITH UNDER-SENSING OR A NORMAL RHYTHM WITH OVER-SENSING, WITH SOME PARTS OF THE ELECTROGRAM (EGM) POSSIBLY SUGGESTING FAR FIELD R-WAVE (FFRW) ATRIAL OVER-SENSING OF THE QRS COMPLEX. 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 11730424 ↗
• MalfunctionApr 23, 2021Under-Sensing; Decreased Sensitivity; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED ATRIAL UNDERSENSING AND LOW P-WAVES. IT WAS NOTED THAT THE RV LEAD HAD ELECTRODES TO SENSE THE ATRIUM. 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 11714706 ↗
• MalfunctionOct 21, 2020High Capture Threshold; Unstable Capture Threshold; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH AND UNSTABLE THRESHOLDS. THE RV AND LV LEADS 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 10711237 ↗
• InjurySep 28, 2020Intermittent Capture; Device Dislodged or Dislocated; Intermittent Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT LEAD DISLODGEMENT CAUSING INTERMITTENT NON CAPTURE WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD THREE DAYS POST IMPLANT. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10591865 ↗
• MalfunctionAug 10, 2020Under-Sensing; Device Sensing Problem; Under-Sensing; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE LEAD WAS A SINGLE VDD LEAD. PACES/SENSE IN RV AND SENSES IN RA. ATRIAL SENSING IS EXPECTED.

  Patient problems: No Consequences Or Impact To Patient; Palpitations

  MAUDE report 10383584 ↗
• MalfunctionJun 25, 2020Under-Sensing; Under-Sensing

  IT WAS FURTHER REPORTED THAT THIS LEAD WAS A VDD LEAD, THAT WAS EXHIBITING UNDERSENSING IN THE ATRIUM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10194223 ↗
• InjuryOct 9, 2019High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS. IT WAS ALSO REPORTED THAT HIGH THRESHOLDS WERE NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 9171643 ↗
• MalfunctionJan 28, 2019Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD, WHICH ALSO SENSES IN THE RIGHT ATRIUM, WAS POSSIBLY UNDERSENSING IN THE ATRIUM. 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 8282317 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INFECTION OCCURRED. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8237394 ↗
• InjuryNov 9, 2018Signal Artifact/Noise; Failure to Sense; Signal Artifact/Noise; Failure to Sense

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS NOT SENSING AND DISPLAYED NOISE. THE RA LEAD WAS REPROGRAMMED, 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 8057185 ↗
• MalfunctionAug 24, 2018Failure to Capture; Pacing Problem; Under-Sensing; Failure to Capture; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NO CAPTURE. IT WAS ALSO REPORTED THAT THERE WAS INTERMITTENT ATRIAL U NDERSENSING WHICH LED TO FLUCTUATING VENTRICULAR PACING RATES. IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING LOW RATES. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 7814862 ↗
• InjuryDec 7, 2017Failure to Capture; Device Dislodged or Dislocated; Unstable Capture Threshold; Failure to Capture; Device Dislodged or Dislocated; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED ONE DAY POST IMPLANT OF THE LEAD. THERE WAS UNSTABLE THRESHOLDS AND INTERMITTENT LOSS OF CAPTURE. 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 7091537 ↗
• InjuryOct 6, 2017Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT A REMOTE TRANSMISSION SHOWED POTENTIAL OVERSENSING OF THE P WAVES ON THE LEAD. THE SENSITIVITY WAS ADJUSTED AND 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 6922446 ↗

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-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