Use cautionMedical device recall · FDA · Published April 16, 2021
Aesculap PAS-PORT Proximal Anastomosis System Recall: Deployment Failure Risk
Aesculap recalls PAS-PORT Proximal Anastomosis System (FC700SU) due to potential deployment failure requiring additional surgery. Affected units include all batch codes.
Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
Take action
Contact the company
📍Recalling firmAesculap Implant Systems LLC3773 Corporate Pkwy · Center Valley, PA 18034-8217
“Aesculap PAS-PORT Proximal Anastomosis System Recall: Deployment Failure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62778-aesculap-pas-port-proximal-anastomosis-system-recall-deployment-failure-risk. Based on FDA recall #Z-2578-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2578-2021%22&limit=1).
Aesculap Implant Systems LLC recalled the PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM (Catalog No. FC700SU) due to deployment failure risks, according to the FDA on April 16, 2021.
How to tell if you have it
Brand: Aesculap Implant Systems LLC
Product: PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
Catalog Number: FC700SU
All batch codes
The hazard
The implant may not deploy successfully, which could necessitate additional medical intervention and result in a potential delay in surgery.
Context
GovInfoNow's records show Aesculap Implant Systems LLC has 26 other recalls on record since August 10, 2017. Other recent recalls of similar products include Bolton Medical RelayPro Thoracic Stent-Graft System Recall (April 22, 2026) and Boston Scientific AXIOS Stent Recall (December 19, 2025).
How to tell if you have this one
Check for the catalog number FC700SU on the product. All batch codes are affected by this recall.
Brand
Aescul: Aesculap Implant Systems LLC
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution in the states of FL, MI, NY, TX, WI.
Recall number
Product, codes & lots
Quantity
Z-2578-2021
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU; All batch codes
80 units
Z-2579-2021
PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13; All batch codes
350 units
Based on the official FDA remedy
What to do — step by step
Contact Your Surgeon
Talk to your surgeon about whether you have the recalled PAS-PORT Proximal Anastomosis System (FC700SU).
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of FL, MI, NY, TX, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Michigan, New York, Texas, Wisconsin.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2578-2021 (April 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2578-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.