The Recall Desk
HighFDA (Devices)·Z-2578-2021·Announced 2021-10-06

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
Category
Medical Device — Surgical Implant
Hazard
  • deployment-failure
  • device-malfunction

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.

Related recalls

Same category