Perceval S Single Use Accessory Kit ICV1346Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08022057015228), received between Oct 20, 2021 and Feb 22, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  ON (B)(6) 2022, A PERCEVAL VALVE IMPLANT ATTEMPT OCCURRED. AS REPORTED, THE SURGEON MADE THREE ATTEMPTS TO DEPLOY THE PERCEVAL VALVE WITHOUT SUCCESS. BASED ON THE MEDICAL JUDGMENT RECEIVED, THE VALVE IS NOT INVOLVED IN THE REPORTED EVENT. THE DIFFICULTIES CAME FROM THE SLIDING OF THE DUAL HOLDER'S SHEATH WHICH WAS STUCK. WHEN THE SURGEON ACHIEVED TO UNLOCK THE SHEATH, THE VALVE WAS DEPLOYED IN THE WRONG POSITION. ULTIMATELY, THE SURGEON USED A NEW PERCEVAL VALVE (OF THE SAME SIZE) AND A NEW ACCESSORY KIT. THIS TIME, IT WAS POSSIBLE TO DEPLOY THE VALVE CORRECTLY AT THE FIRST ATTEMPT, BUT STILL WITH SLIDING DIFFICULTIES. NO COLLAPSING DIFFICULTIES REPORTEDLY OCCURRED. AS REPORTED, THE PATIENT WAS NOT ADVERSELY IMPACTED BY THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13581805 ↗
• InjuryOct 20, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  ON (B)(6) 2021, A PERCEVAL VALVE PVS23 WAS ATTEMPTED TO BE IMPLANTED AS PART OF AN AORTIC VALVE REPLACEMENT PROCEDURE. IT WAS REPORTED THAT NO PROBLEMS WERE ENCOUNTERED DURING THE VALVE SIZING, COLLAPSING AND PARACHUTING. THE PERCEVAL VALVE WAS CORRECTLY DEPLOYED ON THE ANNULUS BUT DIFFICULTIES WERE ENCOUNTERED DURING THE RETRACTION OF THE TRANSPARENT SHEET OF THE DUAL HOLDER TO DEPLOY THE STENT IN THE AORTA. THE PLASTIC SHEATH APPEARED LOCKED. THE SURGEON ATTEMPTED SEVERAL TIMES, WHILE MAINTAINING THE HOLDER AND THE GUIDING SUTURE IN PLACE. AT THIS POINT, THE VALVE MOVED UP TO THE ANNULUS, THUS THE VALVE HAD TO BE REMOVED. THE PROCEDURE WAS REPEATED AND THE SECOND TIME THE SAME DIFFICULTIES WERE IDENTIFIED DURING THE VALVE DEPLOYMENT (SAME DUAL HOLDER WAS USED). THE SURGEON PULLED STRONGLY ON THE TRANSPARENT SHEET AND FINALLY THE VALVE WAS SUCCESSFULLY DEPLOYED. THE TOE SHOWS GOOD RESULTS. THERE WAS AN EXTENSION OF 30MIN TO THE EXTRACORPOREAL CIRCULATION, BUT THE PATIENT REMAINED STABLE DURING THE DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12668674 ↗
• InjuryOct 20, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  ON (B)(6) 2021, A PERCEVAL VALVE PVS23 WAS ATTEMPTED TO BE IMPLANTED AS PART OF AN AORTIC VALVE REPLACEMENT PROCEDURE. IT WAS REPORTED THAT NO PROBLEMS WERE ENCOUNTERED DURING THE VALVE SIZING, COLLAPSING AND PARACHUTING. THE PERCEVAL VALVE WAS CORRECTLY DEPLOYED ON THE ANNULUS BUT DIFFICULTIES WERE ENCOUNTERED DURING THE RETRACTION OF THE TRANSPARENT SHEET OF THE DUAL HOLDER TO DEPLOY THE STENT IN THE AORTA. THE PLASTIC SHEATH APPEARED LOCKED. THE SURGEON ATTEMPTED SEVERAL TIMES, WHILE MAINTAINING THE HOLDER AND THE GUIDING SUTURE IN PLACE. AT THIS POINT, THE VALVE MOVED UP TO THE ANNULUS, THUS THE VALVE HAD TO BE REMOVED. THE PROCEDURE WAS REPEATED AND THE SECOND TIME THE SAME DIFFICULTIES WERE IDENTIFIED DURING THE VALVE DEPLOYMENT (SAME DUAL HOLDER WAS USED). THE SURGEON PULLED STRONGLY ON THE TRANSPARENT SHEET AND FINALLY THE VALVE WAS SUCCESSFULLY DEPLOYED. THE TOE SHOWS GOOD RESULTS. THERE WAS AN EXTENSION OF 30MIN TO THE EXTRACORPOREAL CIRCULATION, BUT THE PATIENT REMAINED STABLE DURING THE DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12668600 ↗