Supple Peri-GuardRecalls & reported problems across all models
Synovis Life Technologies, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Supple Peri-Guard model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 9 models of Supple Peri-Guard by Synovis Life Technologies, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
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
Supple 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-1380-2024 · 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-1378-2024 · Root cause: Labeling Change Control · names 4 of these models · Recall details · FDA record ↗
Supple Peri-Guard models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Supple Peri-Guard PC0404SNMesh, surgical1 recall0 reports
- Supple Peri-Guard PC0608SNMesh, surgical, collagen, diaphragmatic hernia1 recall0 reports
- Supple Peri-Guard PC0814SNPATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE1 recall0 reports
- Supple Peri-Guard PC1016SNMesh, surgical, collagen, diaphragmatic hernia1 recall0 reports
- Supple Peri-Guard SPG0608Mesh, surgical1 recall0 reports
- Supple Peri-Guard SPG0814Intracardiac patch or pledget, biologically derived1 recall0 reports
- Supple Peri-Guard SPG1016Intracardiac patch or pledget, biologically derived1 recall0 reports
- Supple Peri-Guard SPG0404Mesh, surgical1 recall0 reports
- Supple Peri-Guard SPG0406Intracardiac patch or pledget, biologically derived1 recall0 reports
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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