Aesculap recalls PAS-PORT Proximal Anastomosis Devices (US Catalog FG-000001-13) due to potential deployment failure requiring additional surgery. Affected devices may need extra medical intervention.
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 Devices (US Catalog FG-000001-13) because they may not deploy correctly, which could require additional surgery for patients. This risk delays treatment and increases medical complications.
The device may not deploy properly during surgery, requiring additional medical procedures. This can delay critical treatment and increase complications for patients needing the device.
Patients who received this device during surgery are most at risk. The recall affects all devices with the specified US catalog number.
Check for the US catalog number FG-000001-13 on the device packaging. All batch codes are affected by this recall.
Reach out to Aesculap Implant Systems LLC for guidance on next steps after the recall.
The device may not deploy correctly during surgery, requiring additional medical procedures and delaying treatment.
Contact Aesculap Implant Systems LLC for guidance on next steps after the recall.
The recall does not specify a deadline for action.
We’ve drafted a message you can send Aesculap to request your refund or repair — edit it as you like.
Subject: Recall Z-2579-2021 — Aesculap Aesculap Hello, I own a Aesculap that is covered by recall Z-2579-2021 from Aesculap. 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.