Aesculap PAS-PORT Surgical Implant Recalled for Deployment Failure
Aesculap Implant Systems is recalling 80 units of the PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM because the implant may fail to deploy during surgery, potentially requiring additional medical intervention.
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: This FDA Class II device recall involves a malfunction where the implant failed to deploy, potentially requiring additional surgical intervention. No illnesses or injuries have been reported in the source material, making this a risk-of-harm situation where patient harm is possible but has not yet occurred.
Plain-English summary
Aesculap Implant Systems LLC is recalling 80 units of the PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM (Catalog Number FC700SU) due to a reported device malfunction. The implant failed to deploy successfully in clinical use, which may necessitate additional medical intervention for patients.
The recalled devices were distributed nationwide in Florida, Michigan, New York, Texas, and Wisconsin. All batch codes of this product are affected by the recall.
Patients and healthcare providers who have received this device should contact Aesculap Implant Systems LLC for information about appropriate next steps. Healthcare facilities should review their inventory and consult with the manufacturer regarding replacement or alternative options.
The recalled product
- Product
- PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
- Manufacturer
- Aesculap Implant Systems LLC
- Affected units
- 80
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
Part of a larger recall action
This product is one of 2 recalled by Aesculap Implant Systems LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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