Surgical Retractor Grip Cables May Fray or Break During Use
Intuitive Surgical is recalling 738 units of the 8MM Atrial Retractor (Model 470246) due to reports of frayed or broken grip cables on reusable instruments. The defect could compromise instrument performance during surgical procedures.
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: This is an FDA Class II medical device recall for a surgical instrument with a mechanical defect (frayed or broken grip cables). The defect presents a risk of compromised instrument function during surgical procedures. No injuries or deaths have been reported in the source text. Per the rubric, this qualifies as High (Score 3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling 738 units of the 8MM Atrial Retractor Short Right (Model 470246, Part Number 470246-09) following increased complaints of frayed or broken grip cables on reusable instruments with jaws.
The grip cable defect could impair the instrument's ability to function properly during surgical use. Affected units were distributed nationwide throughout the United States and internationally to multiple countries including Canada, Europe, Asia, Australia, and other regions.
The recall includes units with batch numbers K10230219, K10230226, K10230525, K10230601, K10230608, K10230615, K10231218, K10240104, K10240111, K10240411, K10240613, K10240620, K10240711, and K10240725. The device uses UDI-DI code 00886874112397.
Healthcare facilities and surgeons using affected retractors should cease use and contact Intuitive Surgical, Inc. for instructions regarding replacement or repair of affected instruments.
The recalled product
- Product
- 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- grip-cable-fraying
- cable-breakage
- mechanical-failure
Distribution
Distribution scope not specified by the agency.
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