Perceval RELYON PAK PAK-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08022057015556), received between Jun 4, 2025 and Jun 4, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated at the User Facility” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2025Material Fragmentation; Device Contaminated at the User Facility; Material Fragmentation; Device Contaminated at the User Facility

  THE MANUFACTURER WAS INFORMED THAT, DURING THE IMPLANTATION OF A PERCEVAL PLUS SIZE L SUTURELESS BIOPROSTHESIS, LOOSE PLASTIC FRAGMENTS WERE OBSERVED ON THE DELIVERY SYSTEM. REPORTEDLY, THE FRAGMENTS WERE NOTICED WHILE GUIDING SUTURES WERE BEING INSERTED THROUGH THE PROSTHESIS EYELETS. ACCORDING TO THE SURGEON'S EVALUATION, IT WAS SUSPECTED THAT THE FRAGMENTS ORIGINATED FROM THE SILICONE COMPONENT OF THE DELIVERY SYSTEM. AS REPORTED, THE PERCEVAL PROSTHESIS (SN: (B)(6) WAS ULTIMATELY IMPLANTED WITHOUT ANY REPORTED COMPLICATIONS. THE MANUFACTURER HAS BEEN INFORMED THAT THE DELIVERY SYSTEM IN QUESTION WILL NOT BE RETURNED; HOWEVER, A PLASTIC FRAGMENT HAS BEEN RECEIVED FOR ANALYSIS. THE MANUFACTURER IS FOLLOWING UP WITH THE INVOLVED SURGEON TO RETRIEVE ADDITIONAL DETAILS ON THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22141440 ↗

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