Peri-Guard PC1016NRecalls & 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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00085412530604), received between Jul 31, 2018 and Jul 31, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Product Quality Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Feb 28, 2024Open, Classified
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.
Z-1377-2024 · Root cause: Labeling Change Control · FDA record ↗
Most reported problems
Device problems
- Product Quality Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2018Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THE TEMPERATURE INDICATOR OF A PERI-GUARD HAD TURNED WHITE. THIS EVENT WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 7737540 ↗
Other Mesh, surgical devices
- MEDPOR TITAN 81032Stryker Leibinger GmbH & Co. KG · Mesh, surgical1 recall1 report
- Supple Peri-Guard SPG0404Synovis Life Technologies, Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-403-001Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-006Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-019Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-001-009Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-004-105Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- RevizeTM-X 611-005-001Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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