AURORA Surgiscope System Recalled for Potential Sheath Damage
Integra LifeSciences is recalling 14 units of the AURORA Surgiscope System due to potential sheath damage that could cause tissue damage or internal bleeding.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with potential for serious patient harm (tissue damage and hemorrhage). Per the severity rubric, this qualifies as a risk-of-harm product; no illnesses or injuries have been reported, which limits the score to High rather than Severe.
Plain-English summary
The FDA has issued a recall of the AURORA Surgiscope System, a sterile, single-use surgical device manufactured by Integra LifeSciences Corp. The device contains a Sheath, Obturator, and Imager.
The recall was initiated because the device's sheath may be damaged, which could lead to tissue damage and track hemorrhage during use.
The recall affects 14 units with Lot No. 7336314 (Model No. ASX9/130; UDI# 00850002332278) distributed domestically in New York, Ohio, and the District of Columbia.
Healthcare providers and surgical facilities that have received this product should discontinue use and contact Integra LifeSciences Corp. for instructions on product return or replacement.
The recalled product
- Product
- AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
- Manufacturer
- Integra LifeSciences Corp.
- Category
- Medical Device — Surgical Device
- Hazard
- sheath-damage
- tissue-damage
- hemorrhage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. ASX9/130
- UDI# 00850002332278
- Lot No. 7336314.
Distribution
Distributed in 3 states:
- DC
- NY
- OH
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