Transvene®-CS/SVC 6937A-35 (UDI 00613994492388)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00613994492388), received between Jan 14, 2019 and Nov 18, 2025 — classified as 10 injuries, 4 malfunctions.

The most frequently reported specific device problem is “High impedance” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) EPICARDIAL PACING LEAD EXHIBITED AN ABRUPT INCREASE IN IMPEDANCE. THE RV DEFIBRILLATION COIL LEAD EXHIBITED VARIABLE IMPEDANCE WITH A HIGH UNDEFINED MEASUREMENT NOTED. 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 23580030 ↗
• MalfunctionJul 3, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) PACING LEAD TRIGGERED AN ALERT FOR UNDEFINED HIGH PACING IMPEDANCE. ADDITIONALLY, THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD ALERTED FOR UNDEFINED HIGH DEFIBRILLATION IMPEDANCE. 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 22395317 ↗
• InjuryMay 16, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE DEFIBRILLATION RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE (OOR) DEFIBRILLATION IMPEDANCE. IT WAS ALSO REPORTED THAT THE EPICARDIAL PACING RV LEAD EXHIBITED A RISING TREND IN PACING IMPEDANCE MEASUREMENTS. THE DEFIBRILLATION LEAD AND EPICARDIAL 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 19333642 ↗
• MalfunctionJan 10, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT WAS WALKING TO SCHOOL AND COLLAPSED. THE PATIENT HAD NO PULSES THOUGH HAD A NORMAL RHYTHM. IT WAS FURTHER REPORTED THE PATIENT PASSED AWAY. A POST-MORTEM DEVICE INTERROGATION SHOWED MULTIPLE VT-NS EPISODES AND OCCASIONAL VENTRICULAR UNDERSENSING OF THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED. THE VT-NS EVENTS WERE REPORTED TO HAVE OCCURRED WELL INTO ATTEMPTING TO RESUSCITATE THE PATIENT. IT WAS NOTED BY THE HEALTH CARE PROFESSIONAL THERE WERE NO ARRHYTHMIAS LEADING UP TO THE EVENT, WITH NO SHOCKS, AND NO EVIDENCE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM DID NOT FUNCTION AS INTENDED. THE UNDERSENSING DURING RESUSCITATION ATTEMPTS DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134564 ↗
• InjuryMay 20, 2022Fracture; High impedance; Device Markings/Labelling Problem; Impedance Problem; Fracture; High impedance; Device Markings/Labelling Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR HIGH SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE, THAT THE LEAD HAD ALSO HAD VARIANCES IN ITS SVC COIL IMPEDANCE AND THAT THE LEAD WAS FRACTURED. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. IT WAS ADDITIONALLY NOTED THAT THE LEAD IS BEING USED OFF-LABEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462781 ↗
• InjuryFeb 16, 2022Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A POSSIBLE FRACTURE AND EXHIBITED HIGH UNDEFINED OUT OF RANGE (OOR) RV DEFIBRILLATION IMPEDANCE. 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 13543613 ↗
• InjuryDec 7, 2021Adverse 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 REMOVED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12956210 ↗
• InjuryApr 19, 2021High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED BY THE PATIENT'S FAMILY MEMBER THAT THEY WERE HEARING AN AUDIBLE TONE AND WERE WONDERING IF IT WAS COMING FROM THE PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IT WAS FURTHER REPORTED THAT LEAD WARNINGS HAD TRIGGERED DUE TO A SPIKE TO HIGH INFINITE RIGHT VENTRICULAR (RV) PACING IMPEDANCE, AND A SPIKE TO HIGH INFINITE RV DEFIBRILLATOR COIL IMPEDANCE MEASUREMENTS. THE RV 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 11689276 ↗
• InjuryJul 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROUTINE GENERATOR CHANGE, THE CHRONIC RIGHT VENTRICULAR (RV) LEAD BECAME DISLODGED AND WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10251679 ↗
• InjuryOct 25, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A FRACTURE AND WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9241192 ↗
• InjurySep 9, 2019Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT (LIA) TRIGGERED, AND THE PACE/SENSE RIGHT VENTRICULAR (RV) LEAD EXHIBITED POSSIBLE OVERSENSING AND AN INCREASED SENSING INTEGRITY COUNTER (SIC). ADDITIONALLY, THE HIGH VOLTAGE RV LEAD EXHIBITED HIGH/UNDEFINED IMPEDANCES. IT WAS SUSPECTED THAT BOTH LEADS HAD FRACTURED. THE LEADS WERE 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 8975271 ↗
• InjuryMay 22, 2019Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem

  IT WAS FURTHER REPORTED THAT IMPEDANCE SPIKES AND VARIABLE IMPEDANCE VALUES WERE OBSERVED ON THE RV LEAD.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 8633449 ↗
• MalfunctionJan 17, 2019High impedance; High impedance

  IT WAS REPORTED THAT AN ALLIED HEALTH PROFESSIONAL (AHP) CALLED IN TO INQUIRE ABOUT A PATIENT'S RIGHT VENTRICULAR (RV) LEAD THAT HAS RECENTLY DISPLAYED HIGH/UNDEFINED RV DEFIBRILLATION COIL IMPEDANCE. IT WAS NOTED THAT THE LEAD WAS CONNECTED TO A COMPETITOR DEVICE. TESTING OPTIONS WERE PRESENTED TO THE CALLER, BUT IT IS NOT KNOWN IF TESTING OR REPROGRAMMING WAS COMPLETED. 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 8258597 ↗
• MalfunctionJan 14, 2019Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT'S LEAD IMPEDANCE MEASUREMENTS WERE VARYING AND THAT THE, "SHOCKING COIL WAS WRAPPED AROUND THE HEART IN THE PERICARDIAL SPACE." A PARTICULAR LEAD WAS NOT SPECIFIED, BUT BOTH LEADS 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 8245165 ↗