PERCEVAL PVS25 (UDI 08022057014719)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08022057014719), received between Dec 17, 2021 and Sep 4, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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.

• InjurySep 4, 2025Degraded; Degraded

  INFORMATION OBTAINED FROM A PUBLISHED PAPER ENTITLED: " EMERGENCY TRANSCATHETER AORTIC VALVE IN SUTURELESS VALVE REPLACEMENT FOR MANAGING CARDIOGENIC SHOCK", BY ALESSANDRO COMIS, ET AL. THE ABSTRACT INDICTED THE FOLLOWING: ¿SUTURELESS AORTIC BIOPROSTHESIS (SBVS) MAY POSE SPECIFIC CHALLENGES TO VALVE-IN-VALVE (VIV) IMPLANTATION, PARTICULARLY, IN THE SETTING OF CARDIOGENIC SHOCK WHICH REMAINS CHALLENGING AND UNDERSTUDIED. PAPER REPORTS A PATIENT WITH A SBVS DISFUNCTION, PRESENTING WITH ACUTE DECOMPENSATED HF. DESPITE INTRA-AORTIC BALLOON PUMP (IABP), CLINICAL DETERIORATION PROMPTED AN EMERGENCY TRANSCATHETER VIV. COMPUTER TOMOGRAPHY IMAGING CONFIRMED PROCEDURAL FEASIBILITY. A SELF-EXPANDING EVOLUT PRO+ VALVE WAS DEPLOYMENT FOLLOWED BY POST-DILATATION FOR UNDER EXPANSION. THE PROCEDURE RESTORED VALVE FUNCTION, AND THE PATIENT WAS WEANED OFF IABP. AT 30-DAY FOLLOW-UP, PATIENT WAS IN NYHA CLASS I WITH COMPLETE RECOVERY OF LEFT VENTRICULAR SYSTOLIC FUNCTION (EF 53%). CAREFUL CT PLANNING AND DEVICE SELECTION ARE CRITICAL. DESPITE THE LACK OF DATA IN THIS SETTING, VIV MAY REPRESENT A SAFE AND EFFECTIVE OPTION FOR HIGH-RISK PATIENTS IN CARDIOGENIC SHOCK (CS)¿. BASED ON THE FURTHER INFORMATI

  Patient problems: Aortic Valve Stenosis

  MAUDE report 22961137 ↗
• InjuryDec 17, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021, A PERCEVAL VALVE PVS25 WAS IMPLANTED IN A PATIENT. THE PATIENT IS RECENTLY DIAGNOSED WITH PNEUMONIA AND STARTED ON ANTIBIOTIC. THE POST-OPT RECOVERY WAS PROLONGED (STILL IN ICU DUE TO THROMBOCYTOPENIA). THE PATIENT HAS BEEN UNDER OBSERVATION SINCE 1 DAY POSTOP UNTIL (B)(6) 2021. IT IS PRESENTLY UNKNOWN IF THE PATIENT RECOVERED OR IS STILL UNDER TREATMENT. THE PATIENT¿S PRE-OPERATIONAL ASSESSMENT HAS NO OTHER COMORBID CONDITION BESIDE THE OLD AGE. THE PATIENT WAS TESTED WITH A SUPPORT OF A HEMATOLOGIST AND THE RESULT TESTED NOTHING RELATED TO PATIENT'S PLATELET. THE PERCEVAL VALVE WAS SUSPECTED AS A POSSIBLE CONTRIBUTING FACTOR TO THROMBOCYTOPENIA.

  Patient problems: Thrombocytopenia

  MAUDE report 13030538 ↗
• InjuryDec 17, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021, A PERCEVAL VALVE PVS25 WAS IMPLANTED IN A PATIENT. THE PATIENT IS RECENTLY DIAGNOSED WITH PNEUMONIA AND STARTED ON ANTIBIOTIC. THE POST-OPT RECOVERY WAS PROLONGED (STILL IN ICU DUE TO THROMBOCYTOPENIA). THE PATIENT HAS BEEN UNDER OBSERVATION SINCE 1 DAY POSTOP UNTIL (B)(6) 2021. IT IS PRESENTLY UNKNOWN IF THE PATIENT RECOVERED OR IS STILL UNDER TREATMENT. THE PATIENT¿S PRE-OPERATIONAL ASSESSMENT HAS NO OTHER COMORBID CONDITION BESIDE THE OLD AGE. THE PATIENT WAS TESTED WITH A SUPPORT OF A HEMATOLOGIST AND THE RESULT TESTED NOTHING RELATED TO PATIENT'S PLATELET. THE PERCEVAL VALVE WAS SUSPECTED AS A POSSIBLE CONTRIBUTING FACTOR TO THROMBOCYTOPENIA.

  Patient problems: Thrombocytopenia

  MAUDE report 13030408 ↗

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