CAPSURE VDD-2Recalls & reported problems across all models
Medtronic, Inc. · 9 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 69
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls
- 0
We found 9 models of CAPSURE VDD-2 by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 69 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2017 and Sep 7, 2026 — classified as 39 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Under-Sensing” (24 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CAPSURE VDD-2 problems
Device problems
- Under-Sensing24
- Over-Sensing13
- High Capture Threshold11
- Adverse Event Without Identified Device or Use Problem10
- Failure to Capture10
- Signal Artifact/Noise8
- Capturing Problem5
- High impedance5
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Known Impact Or Consequence To Patient18
- Unspecified Infection9
- No Consequences Or Impact To Patient7
- Dizziness3
- Syncope3
- Bradycardia2
- Dyspnea2
CAPSURE VDD-2 models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CAPSURE® VDD-2 5038-58permanent pacemaker Electrode21 reports
- Capsure® VDD-2 5038S-52permanent pacemaker Electrode15 reports
- CapSure® VDD-2 5038S-58permanent pacemaker Electrode10 reports
- CAPSURE® VDD-2 5038-58Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes10 reports
- CAPSURE® VDD-2 5038S-52Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes4 reports
- CAPSURE® VDD-2 5038-65permanent pacemaker Electrode4 reports
- CAPSURE® VDD-2 5038S-58Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes3 reports
- Capsure® VDD-2 5038S-58Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes1 report
- CapSure® VDD-2 5038S-52permanent pacemaker Electrode1 report
Recent CAPSURE VDD-2 adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗MalfunctionAug 26, 2024Signal Artifact/Noise; Electrical /Electronic Property Problem; Over-Sensing; Low impedance; Signal Artifact/Noise; Electrical /Electronic Property Problem; Over-Sensing; Low impedance
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE, OVERSENSING, LOW IMPEDANCE AND UNDERWENT A POLARITY SWITCH. 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 20062565 ↗InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO AN INFECTION, AND REPLACED BY A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT..
Patient problems: Unspecified Infection
MAUDE report 19711630 ↗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 ↗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 ↗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 ↗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 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- Intellis AdaptiveStim3 models · 35,469 reports
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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