PhotoFix Decellularized Bovine Pericardium PFP0.8X8Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00877234000553), received between Mar 15, 2019 and Mar 11, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

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.

• MalfunctionMar 11, 2020Device Markings/Labelling Problem

  UPPER MIDDLE AGED MALE WITH HISTORY OF CAROTID ARTERY STENOSIS, HYPERTENSION AND PERIPHERAL VASCULAR DISEASE. WHEN THE SURGEON WENT TO USE THE CRYOLIFE, PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM PATCH, HE WAS UNABLE TO IDENTIFY ROUGH SIDE FROM THE SMOOTH SIDE. THEREFORE, UNABLE TO USE FOR PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9817827 ↗
• InjuryNov 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO INITIAL REPORTS, PATIENT ENROLLED IN PHOTOFIX-V STUDY EXPERIENCED MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction

  MAUDE report 9383528 ↗
• InjuryMar 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, (B)(6) WAS ENROLLED INTO THE (B)(6) STUDY ON (B)(6) 2019. THE PATIENT WAS IMPLANTED WITH A PHOTOFIX PATCH AS PART OF HIS LEFT FEMORAL ENDARTERECTOMY PROCEDURE. THE SITE SUBMITTED AN ADVERSE EVENT ELECTRONIC CASE REPORT FORM (ECRF) REPORTING PAIN IN THE LEFT GROIN. THE PATIENT WENT TO HIS PMD WHERE HE WAS PRESCRIBED A 7 DAY COURSE OF CIPROFLOXACIN 500MG. THERE WERE NO ADDITIONAL DETAILS PROVIDED ON SYMPTOMS, EVIDENCE OF INFECTION, OR RELATION TO THE PATIENT¿S SURGERY OR PHOTOFIX. THE PARTIALLY COMPLETED ADVERSE EVENT ECRF IS ATTACHED. THE SITE WAS ASKED TO PROVIDE ANSWERS TO THE EVENT¿S RELATION TO THE SURGERY AND TO PHOTOFIX. THE SITE IS EXPECTED TO ALSO FINISH COMPLETION OF THE ECRF. THE SITE RESPONSE AND COMPLETED ECRF IS CURRENTLY PENDING. ADDITIONAL INFORMATION INDICATES DATE OF SURGERY WAS (B)(6) 2019. THE PAIN EXPERIENCED BY PATIENT BEGAN ON (B)(6) 2019. THE EVENT WAS REPORTED ON (B)(6) 2019 AND RESOLVED ON (B)(6) 2019. PER THE OFFICE NOTE OF THE OPERATING SURGEON FROM (B)(6) 2019, " STATUS POST LEFT LEG PROFUNDA ENDARTERECTOMY; HAS SOME PAIN IN THE LEFT GROIN; WAS CONCERNED ABOUT REDNESS AND WENT TO HIS PMD WHO STARTED HIM ON A 7 DAY COURSE O

  Patient problems: Pain

  MAUDE report 8426010 ↗