Transvene®-CS/SVC 6937A-52 (UDI 00613994492401)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994492401), received between Mar 26, 2019 and May 21, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “High impedance” (3 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, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). IT WAS NOTED THAT SIC COUNTERS IN SOME OF THE STORED EPISODES WERE INCREMENTING QRS DOUBLE COUNTING. 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 25247948 ↗
• InjuryMay 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A DEVICE UPGRADE IMPLANT PROCEDURE, THE PATIENT HAD ISSUES AND WAS IMMEDIATELY BROUGHT BACK TO THE OPERATING ROOM (OR). IT WAS NOTED THAT THE EXISTING RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) EPICARDIAL LEADS WERE CONSTRICTING THE CORONARY ARTERIES. THE DEVICE SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest; Vasoconstriction; Ventricular Fibrillation

  MAUDE report 17034872 ↗
• InjuryMay 10, 2021High impedance; High impedance

  IT WAS REPORTED THAT A REMOTE MONITORING TRANSMISSION WAS RECEIVED AND WAS REVIEWED. ALERTS WERE NOTED TO HAVE BEEN TRIGGERED FOR HI GH/UNDEFINED SUPERIOR VENA CAVA COIL IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD AS WELL AS FOR HIGH/UNDEFINED ATRIAL IMPEDANCE A FEW YEARS EARLIER. THE SVC COIL WAS NOTED TO HAVE BEEN PROGRAMMED OFF AND THE DEVICE WAS NOTED TO BE IN VVI MODE. THE 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 11799806 ↗
• InjuryAug 27, 2019Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIGH VOLTAGE COIL LEAD EXHIBITED HIGH IMPEDANCES AND A POSSIBLE FRACTURE. THE LEAD WAS 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 8937456 ↗
• MalfunctionMar 26, 2019High impedance; High impedance

  IT WAS REPORTED THAT THERE WAS A HIGH SVC (SUPERIOR VENA CAVA) COIL IMPEDANCE ALERT TRIGGERED FOR THE PATIENT¿S DEFIBRILLATION LEAD. 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 8453683 ↗