PERCEVAL PVS27 (UDI 08022057014726)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08022057014726), received between Sep 9, 2022 and Apr 15, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Incomplete Coaptation” (1 report).

1 other recall cover devices cleared under the same FDA submission (P150011); they may or may not involve this specific model.

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

• InjuryApr 15, 2023Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2023, A PERCEVAL SUTURELESS AORTIC HEART VALVE SIZE XL WAS IMPLANTED IN THE AORTIC POSITION. HOWEVER, A CENTRAL LEAK WAS ENCOUNTERED IN THE VALVE IN ECHO IMAGE, AND THEN THE VALVE WAS REMOVED AND A 25MM BIOLOGICAL VALVE WAS IMPLANTED. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE PVS VALVE WAS IMPLANTED WITHOUT ANY PROBLEMS, AND THEN THE BALLOON WAS APPLIED AS USUAL. AFTER THE AORTOTOMY WAS CLOSED AND REPERFUSION WAS STARTED, AND SEVERE AORTIC INSUFFICIENCY WAS DETECTED. INTRAOPERATIVE TEE WAS ALSO APPLIED WHEN THE PUMP WAS REMOVED. SEVERE AORTIC INSUFFICIENCY WAS DETECTED BOTH HEMODYNAMICALLY AND TEE. AORTIC REGURGITATION WAS EVALUATED AS CENTRAL, AND A MINIMAL PARAVALVULAR LEAK WAS ALSO DETECTED. ABOVE THIS, THE PUMP WAS RE-ENTERED, AND THE VALVE WAS EXPLANTED. IT WAS DETERMINED THAT THERE WAS AN EFFECT ON THE LID AFTER EXPLANTATION. REPORTEDLY, ONE CUSP WAS SMALLER THAN THE OTHERS AND WAS NOT FULLY CLOSED. BASED ON THE FURTHER INFORMATION RECEIVED, PATIENT REMAINED STABLE THROUGH THE DELAY IN PROCEDURE AND PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT ANY PROBLEMS.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16748386 ↗
• InjuryJan 17, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2022, CENTRAL LEAK AND PARAVALVULAR LEAK WAS OBSERVED BY TEE AFTER IMPLANTING THE PERCEVAL VALVE SIZE XL THROUGH FULL STERNOTOMY. REPORTEDLY, THIS PERCEVAL VALVE WAS IMPLANTED BEFORE CORONARY ARTERY BYPASS AND HEART LUXATION. ULTIMATELY, IT WAS DECIDED TO REMOVE THE VALVE. ANOTHER XL VALVE WAS ULTIMATELY IMPLANTED IN THE PATIENT WITH A GOOD RESULT. BASED ON THE FURTHER INFORMATION RECEIVED, NO MALFUNCTION WITH THE VALVE WAS NOTED, THERE WAS NO IMPACT ON THE PATIENT, APPROXIMATELY 20 MINUTES WAS ADDED TO THE PROCEDURE AS A RESULT OF THE REPORTED EVENT, AND PATIENT WAS STABLE THROUGH THE DELAY IN THE PROCEDURE. BASED ON THE MEDICAL JUDGEMENT RECEIVED, IT IS POSSIBLE THAT DEVICE DISLODGMENT HAS BEEN OCCURRED DUE TO THE MANEUVERS AND LED TO THE REPORTED REGURGITATION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16187661 ↗
• InjurySep 9, 2022Perivalvular Leak; Perivalvular Leak

  THE MANUFACTURER WAS INFORMED OF A PERIVALVULAR LEAK AFTER IMPLANT OF PERCEVAL SURTURELESS AORTIC HEART VALVE, PVS27/SIZE XL. THE VALVE WAS IMPLANTED ON (B)(6) 2020. AS REPORTED, THEY WERE PLANNING TO IMPROVE PARAVALVULAR LEAK BY INTERVENTIONAL TREATMENT, SUCH AS PLACE AN OCCLUDER OR DILATION AGAIN WITH A BALLOON. BASED ON THE INFORMATION RECEIVED, THE PERIVALVULAR LEAK APPEARED IMMEDIATELY AFTER PROCEDURE WAS FINISHED, AND THE AR WAS 3+. REPORTEDLY, SURGEONS DON¿T THINK THAT THIS WAS A PRODUCT ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 15388595 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150011. One submission often covers many models, so check the product and lot details in each record.

• Z-0716-2017 · Oct 31, 2016 · Terminated
  Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart