Transvene®-CS/SVC 6937A-58 (UDI 00613994492418)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994492418), received between May 15, 2019 and Nov 7, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “High impedance” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025High impedance; High impedance

  IT WAS REPORTED THAT REVIEW OF A REMOTE TRANSMISSION SHOWED THE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION COIL LEAD TRIGGERED ALERTS FOR HIGH OUT OF RANGE (OOR) DEFIBRILLATION IMPEDANCES, AND THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD TRIGGERED ALERTS FOR HIGH RV COIL AND PACING IMPEDANCE OOR AND ABOVE THE PROGRAMMED ALERT THRESHOLD, RESPECTIVELY. BOTH 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 23497433 ↗
• InjuryNov 15, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE SINGLE COIL RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH UNDEFINED PACING IMPEDANCE WITH NOTED VARIATION AS WELL AS HIGH OUT OF RANGE (OOR) DEFIBRILLATION COIL IMPEDANCE WITH NOTED VARIATION AND A SPIKE. IT WAS FURTHER REPORTED THAT THE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION LEAD EXHIBITED HIGH UNDEFINED IMPEDANCE WITH NOTED VARIABILITY AND SPIKES. 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 20696524 ↗
• InjuryMar 11, 2022Adverse 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 A METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION OF UNKNOWN ORIGIN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13731899 ↗
• MalfunctionJul 22, 2021High impedance; High impedance

  IT WAS REPORTED THAT AN ALERT WAS TRIGGERED FOR THE RIGHT VENTRICULAR (RV) LEAD DUE TO HIGH/UNDEFINED PACING IMPEDANCE AND HIGH/UNDEFINED RIGHT VENTRICULAR (RV) DEFIBRILLATION IMPEDANCE. IN ADDITION, AN ALERT WAS TRIGGERED FOR THE RIGHT ATRIAL (RA) LEAD DUE TO HIGH/UNDEFINED PACING IMPEDANCE. THE RA LEAD WAS REMOVED AND REPLACED. 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 12211627 ↗
• InjuryApr 16, 2020Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR OVERSENSING OF NOISE WITH HIGH RATE NON-SUSTAINED AND SENSING INTEGRITY COUNTER (SIC) EPISODES. THE LEAD WAS REPROGRAMMED AND CONTINUES TO BE MONITORED. 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 9970550 ↗
• InjuryMay 15, 2019High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEADS EXHIBITED A WARNING FOR HIGH IMPEDANCE. THE LEAD ALERTS WERE PROGRAMMED OFF AND REMAIN 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 8613400 ↗