Peri-GuardRecalls & reported problems across all models
Synovis Life Technologies, Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Peri-Guard model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 10 models of Peri-Guard by Synovis Life Technologies, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Jul 31, 2018 and Nov 14, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (1 report).
2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Peri-Guard recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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-1379-2024 · Root cause: Labeling Change Control · names 5 of these models · Recall details · FDA record ↗
- 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 · names 4 of these models · Recall details · FDA record ↗
Most reported Peri-Guard problems
Device problems
- Product Quality Problem1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Peri-Guard models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Peri-Guard PC1016NMesh, surgical1 recall1 report
- Peri-Guard PC0404NPATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE1 recall0 reports
- Peri-Guard PC0608NMesh, surgical1 recall0 reports
- Peri-Guard PC0814NMesh, surgical1 recall0 reports
- Peri-Guard PG0404Mesh, surgical, collagen, diaphragmatic hernia1 recall0 reports
- Peri-Guard PG0608Mesh, surgical, collagen, thoracic, chest wall reconstruction1 recall0 reports
- Peri-Guard PG0814Mesh, surgical1 recall0 reports
- Peri-Guard PG1016Mesh, surgical, collagen, diaphragmatic hernia1 recall0 reports
- Peri-Guard PG1225Mesh, surgical, collagen, diaphragmatic hernia1 recall0 reports
- Peri-Guard PC1225NMesh, surgical, collagen, thoracic, chest wall reconstruction1 report
Recent Peri-Guard adverse event reports
The 2 most recent reports across all models, 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 ↗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 Synovis Life Technologies, Inc. products
All Synovis Life Technologies, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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