PAS-PORT Proximal Anastomosis Device recalled for deployment failure risk
Aesculap Implant Systems is recalling the PAS-PORT Proximal Anastomosis Device because the implant may fail to deploy successfully, potentially requiring additional medical intervention during surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The device is a high-risk surgical implant with explicit deployment failure risk that may require additional intervention. FDA Class II classification applies. No illnesses, injuries, or hospitalizations have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3.
Plain-English summary
The FDA has issued a Class II recall of the PAS-PORT Proximal Anastomosis Device US (Catalog Number FG-000001-13), manufactured by Aesculap Implant Systems LLC. All batch codes of this surgical device have been recalled.
The device may not deploy successfully during implantation. A deployment failure may necessitate additional medical intervention for patients and could result in delays to surgical procedures.
Approximately 350 units were distributed nationwide to healthcare facilities in Florida, Michigan, New York, Texas, and Wisconsin.
Healthcare providers and patients who have received or been scheduled for procedures with this device should consult with Aesculap Implant Systems LLC or their healthcare provider. Healthcare facilities should review their inventory and remove affected units from use.
The recalled product
- Product
- PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
- Manufacturer
- Aesculap Implant Systems LLC
- Hazard
- deployment-failure
- surgical-complication-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All batch codes
Distribution
Distributed nationwide across the United States.
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