Bulldog G46542Recalls & reported problems
Cook Vandergrift Inc. · Bulldog Lead Extender · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002465428), received between Apr 15, 2026 and Apr 15, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Tricuspid Valve Insufficiency/ Regurgitation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE FOLLOWING INFORMATION WAS FORWARDED BY MERIT MEDICAL SYSTEMS TO COOK MEDICAL REGARDING A JOURNAL ARTICLE/STUDY TITLED, "TRANSVENOUS EXTRACTION OF PACEMAKER AND DEFIBRILLATOR LEADS AND THE RISK OF TRICUSPID VALVE REGURGITATION". DESCRIPTION AS REPORTED BY MERIT MEDICAL SYSTEMS: "THIS STUDY DESCRIBES THE SCOPE OF SIGNIFICANT TRICUSPID VALVE (TV) INJURY WITH INCREASE IN TRICUSPID REGURGITATION BY USING OF TRANSVENOUS LEAD EXTRACTION (TLE) METHOD FOR LEAD REMOVAL. STUDY WAS CONDUCTED ON QUALIFYING 208 PATIENTS. PERFECTA ELECTROSURGICAL DISSECTION SHEATH AND EVOLUTION ROTATING DILATOR SHEATH WERE USED, AND EVALUATIONS WERE OBSERVED WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WHICH CONCLUDED WITH SIGNIFICANT INCREASE IN TRICUSPID REGURGITATION (TR). OF THE 208 PATIENTS, SIGNIFICANT INCREASE IN TR WAS OBSERVED IN 24 PATIENTS AFTER EXTRACTION WHICH RESULTED IN LONGER POST EXTRACTION HOSPITAL STAY. AS FOR THE MECHANISMS OF ACUTE TRI OBSERVED IN 24 PATIENTS, 7 PATIENTS SHOWED TEE DATA SUGGESTING TV INJURIES. IN 1 PATIENT WITHOUT EVIDENCE OF TV INJURY, AGGRAVATION OF LEFT VENTRICULAR. STUDY SHOWED THAT LEAD AGE WAS IDENTIFIED AS AN INDEPENDENT PREDICTOR IN MULTIVARIATE ANALYSIS AS WELL."
Patient problems: Tricuspid Valve Insufficiency/ Regurgitation
MAUDE report 24888702 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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