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
Aesculap is recalling its PAS-PORT Proximal Anastomosis System (catalog number FC700SU) because it may not deploy correctly, which could delay surgery and require additional medical procedures. This is a serious issue for patients who have received this implant.
The implant may not deploy correctly during surgery, which could lead to the need for additional medical interventions. This might cause delays in the patient's surgery and require extra procedures to fix the issue.
Patients who received the PAS-PORT Proximal Anastomosis System (FC700SU) from Aesculap. Those with the implant are at risk of needing extra surgery if the device doesn't deploy properly.
Check for the catalog number FC700SU on the product. All batch codes are affected by this recall.
Talk to your surgeon about whether you have the recalled PAS-PORT Proximal Anastomosis System (FC700SU).
The recall states the implant may not deploy correctly, which could require additional surgery. It is not safe to assume it works as intended.
Contact your surgeon to determine if you have the recalled product. The manufacturer has not provided a specific remedy for this recall.
Look for the catalog number FC700SU on the product. All batch codes are affected by this recall.
We’ve drafted a message you can send Aescul: Aesculap Implant Systems LLC to request your refund or repair — edit it as you like.
Subject: Recall Z-2578-2021 — Aescul: Aesculap Implant Systems LLC Aescul: Aesculap Implant Systems LLC Hello, I own a Aescul: Aesculap Implant Systems LLC that is covered by recall Z-2578-2021 from Aescul: Aesculap Implant Systems LLC. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
