PhotoFix Decellularized Bovine Pericardium PFP6X8Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00877234000621), received between Oct 6, 2021 and Nov 19, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO INITIAL REPORTS SURGEON HAD "A FEW EARLY THROMBOSIS LATELY". SURGEON HAS BEEN DOING EITHER 81 OR 325 ASPIRIN. THE PRODUCT WAS IMPLANTED AND WILL NOT BE RETURNED. PATIENT IMPACT WAS SURGICAL INTERVENTION. ADDITIONAL INFORMATION REQUESTED. THIS INVESTIGATION IS RELEGATE TO PFP6X8 UNKNOWN LOT NUMBER FOR THROMBOSIS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20723733 ↗
• InjuryJan 9, 2024Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORT, THE PATIENT HAD A PHOTOFIX PATCH IMPLANTED ON (B)(6) 2022 FOR A VENTRICULAR SEPTAL DEFECT (VSD) CLOSURE, PULMONARY ARTERY DEBANDING, PULMONARY ARTERY PATCH RECONSTRUCTION AND DCRV RELEASE. FIVE MONTHS POST-PROCEDURE, ON 16JANUARY2023 THE PATIENT PRESENTED WITH VSD PATCH LEAK AND THE PULMONARY VALVE WAS THICKENED AND DESTROYED. PANNUS WAS NOTED AROUND THE PHOTOFIX. THE PHOTOFIX WAS EXPLANTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18476596 ↗
• InjuryNov 3, 2021Separation Problem; Separation Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED VIA EMAIL ON 06-OCT-2021 FROM CRYOLIFE SALES REPRESENTATIVE (CSR), S.G., THE SURGEON TOLD ME THAT HE'S HAD MULTIPLE ISSUES USING PHOTOFIX ON AORTIC SURGICAL CASES. HE MENTIONED ONE CASE IN PARTICULAR WHERE HE USED PF TO DO A MANAGUAN ROOT ENLARGEMENT. HE SAID THAT THE PATCH NEVER INCORPORATED/REMODELED. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING.

  Patient problems: Unspecified Heart Problem

  MAUDE report 12745392 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  CRYOLIFE SALES REPRESENTATIVE RELAYED THAT PHOTOFIX WAS EXPLANTED FROM THE PATIENT ON (B)(6) 2021. THE PHOTOFIX WAS EXPLANTED DUE TO IT PULLING AWAY FROM THE SUTURE LINE AT THE VALVE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE GONE UNMET.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12583083 ↗