CAPSURE® VDD-2 5038-58 (UDI 00885074201566)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885074201566), received between Jan 28, 2019 and Apr 14, 2026 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Over-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. 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.

• InjuryApr 14, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD APPEARS TO HAVE INSULTATION DAMAGE PER X-RAY. THE LEAD WAS 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 24873276 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. IT WAS ALSO NOTED THAT DURING IMPLANT THE REPLACEMENT RIGHT VENTRICULAR (RV) LEAD EXHIBITED A DAMAGED HELIX. THE LEAD WAS ATTEMPTED/NOT USED. THE SYSTEM WAS REPLACED NINE DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20658106 ↗
• InjuryFeb 15, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) AND IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCING SYNCOPE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 18710405 ↗
• MalfunctionAug 14, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WITH DUAL CHAMBER SENSING CAPABILITY WAS USED OFF LABEL AND EXHIBITED NO SENSING.  THE RIGHT VENTRICULAR (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 17538985 ↗
• MalfunctionAug 2, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS AND SHORTNESS OF BREATH. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED POSSIBLE OVERSENSING. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Dyspnea

  MAUDE report 15144171 ↗
• MalfunctionApr 19, 2021Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED LOSS OF PACING AND IT WAS NOTED THAT THE PATIENT'S HEART RATE WENT BELOW PROGRAMMED PARAMETERS ON THEIR IPG. THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND NOISE. THE RIGHT VENTRICULAR (RV) LEAD ALSO EXHIBITED T-WAVE OVERSENSING (TWOS). THE IPG WAS REPLACED WITH A BI-VENTRICULAR (BI-V) IPG AND BOTH PACING LEADS 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 11683988 ↗
• InjurySep 3, 2020Failure to Capture; Under-Sensing; Failure to Capture; Under-Sensing

  IT WAS REPORTED THAT THIS RV LEAD WAS A VDD LEAD, AND IT EXHIBITED UNDERSENSING IN THE ATRIUM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10486738 ↗
• MalfunctionNov 27, 2019Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING ON STORED ELECTROGRAMS (EGM). 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 9382084 ↗
• InjuryMar 6, 2019Failure to Capture; Electromagnetic Interference; Over-Sensing; Low impedance; Failure to Capture; Electromagnetic Interference; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A WARNING AND POLARITY SWITCH DUE TO LOW IMPEDANCE VALUES AND OVERSENSING. THE LEAD FURTHER EXHIBITED NO CAPTURE AND THE PATIENT EXPERIENCED SYNCOPAL EPISODES. IT WAS NOTED THAT THE OVERSENSING WAS LIKELY DUE TO ELECTROMAGNETIC INTERFERENCE. THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED AND THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope

  MAUDE report 8395111 ↗
• InjuryJan 28, 2019Intermittent Capture; High impedance; Capturing Problem; Impedance Problem; High Capture Threshold; Intermittent Capture; High impedance; Capturing Problem; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYMPTOMS OF PRE-SYNCOPE. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS, WHICH HAD INCREASED RAPIDLY RESULTING IN AN INTERMITTENT LOSS OF CAPTURE. A RAPID INCREASE IN IMPEDANCE WAS ALSO NOTED. THE LEAD WAS REPROGRAMMED, AND THEN CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 8281243 ↗

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