Pulmonary Hemi-Artery SG recallZ-1561-2011 · CryoLife, Inc. · initiated Feb 17, 2011
Terminated All recalls posted in March 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CryoLife, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Staphylococcus aureus (not methicillin resistant) identified in companion tissue.
FDA root cause category: Other
What the company is doing
CryoLife Inc. issued a letter to the physician on February 17, 2011, advising him of the results of the testing performed on a companion cardiac allograft. The letter did not recommend explant of the allograft or special antimicrobial treatment of the patient unless medically necessary. The physician was asked to complete and return the enclosed, stamped, self-addressed postcard affirming the receipt of the notification. For any questions the physician was advised to call 770-419-3355.
Recall details
- Recall number
- Z-1561-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 17, 2011
- Posted by the FDA
- Mar 4, 2011
- Recalling firm
- CryoLife, Inc.
- Quantity
- One
- Product code
- DXZ
- FDA submissions
- K101866
- Distribution
- Nationwide Distribution including AZ & NV
Product description
Pulmonary Hemi-Artery SG Used in heart surgery
Code information (models, lots, serial numbers)
Serial No. 9528019 - Model SGPH00
Other devices under the same FDA submission
2 devices cleared under K101866 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CryoPatch® SG Pulmonary Human Cardiac Branch Patch SGP020Artivion, Inc. · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene2 recalls1 report
- CryoPatch® SG Pulmonary Human Cardiac Hemi-Artery Patch SGPH00Artivion, Inc. · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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