Peri-Guard PC1225NRecalls & reported problems

Synovis Life Technologies, Inc. · Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C. · Class 2 · Implant

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00085412530628), received between Nov 14, 2023 and Nov 14, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Tear, Rip or Hole in Device Packaging1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 14, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE CAP OF A PERI-GUARD REPAIR PATCH BOX WAS CRACKED WHICH COULD COMPROMISE THE STERILITY OF THE PRODUCT. THE DAMAGED COMPONENT WAS FOUND DURING A MEDICAL PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18133301 ↗

Device details

UDI-DI	`00085412530628`
Brand	Peri-Guard
Model	PC1225N
Catalog no.	PC1225NBIO
Company	Synovis Life Technologies, Inc.
Product code	OXB · Mesh, surgical, collagen, thoracic, chest wall reconstruction
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Oct 31, 2023

Device type (GMDN): Cardiovascular patch, animal-derived

An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.

Other Mesh, surgical, collagen, thoracic, chest wall reconstruction devices

Peri-Guard PG0608
Synovis Life Technologies, Inc. · Mesh, surgical, collagen, thoracic, chest wall reconstruction
1 recall0 reports

All Mesh, surgical, collagen, thoracic, chest wall reconstruction devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.