Integra LifeSciences recalls AURORA Surgiscope System due to potential sheath damage causing tissue injury or bleeding. Affected units have specific model and lot numbers.
Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
Integra LifeSc: AURORA Surgiscope System is recalled because the sheath might damage tissue or cause bleeding during use. This is a serious risk for surgical procedures.
The sheath in the device might become damaged during use, which could lead to tissue injury or bleeding. This risk occurs during surgical procedures where the device is used.
Surgical teams using the AURORA Surgiscope System for procedures are most at risk. Patients undergoing surgery with this device could experience tissue damage or bleeding.
Check for model number ASX9/130 and lot number 7336314 on the device packaging or label. The device includes a Sheath, Obturator, and Imager components.
Verify the device includes a Sheath, Obturator, and Imager components with model number ASX9/130 and lot number 7336314.
The recall states potential sheath damage could lead to tissue damage or bleeding, so it is not safe to use without checking the recall.
The recall does not specify a remedy, so contact Integra LifeSciences for guidance on next steps.
Look for model number ASX9/130 and lot number 7336314 on the device packaging or label.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2331-2024 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-2331-2024 from Integra LifeSciences. 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.
