Aesculap recalls DS Titanium Ligation Clip Appliers used in laparoscopic surgery for living donor nephrectomies. Updated instructions add contraindications to prevent misuse.
Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. Updated cleaning and sterilization instructions.
Aesculap is recalling specific laparoscopic surgery clip appliers because they should not be used for living donor kidney removal procedures. This change prevents potential complications from improper use in these surgeries.
The clip appliers have been updated to include a contraindication for living donor nephrectomies. This means they should not be used in these specific surgeries to avoid potential complications from improper application.
Surgical teams performing laparoscopic procedures using these specific clip appliers are affected. The highest risk is for procedures involving living donor nephrectomies.
Check for product numbers PL808R, PL802R, PL826R, PL817R, PL828R, PL809R, PL806R, PL818R, PL801R, PL816R, PL807R, PL822R, or PL827R on the device. These are used in laparoscopic surgery.
Identify if your clip applier has one of the listed product numbers: PL808R, PL802R, PL826R, PL817R, PL828R, PL809R, PL806R, PL818R, PL801R, PL816R, PL807R, PL822R, or PL827R.
The recall adds a contraindication for living donor nephrectomies to prevent potential complications from improper use in these specific surgeries.
Check the product numbers on your device to see if it is recalled. If it is, you do not need to take any action as the device is safe for other procedures.
No, these clip appliers should not be used for living donor nephrectomies. They are safe for other laparoscopic procedures.
We’ve drafted a message you can send Aesculap to request your refund or repair — edit it as you like.
Subject: Recall Z-1291-2018 — Aesculap Aesculap Hello, I own a Aesculap that is covered by recall Z-1291-2018 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.
