Intuitive Surgical DeBakey Forceps Recalled for Frayed or Broken Grip Cables
Intuitive Surgical is recalling 1,739 8MM DeBakey Forceps (Model 470036) used in surgical procedures due to increased reports of frayed or broken grip cables. Cable failure could impair instrument function during surgery.
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 medical device recall addressing mechanical component failure on surgical instruments. No injuries or deaths are reported in the source, but the defect poses a risk-of-harm to surgical patients if instruments malfunction during procedures.
Plain-English summary
Intuitive Surgical, Inc. is recalling 1,739 units of its 8MM DeBakey Forceps (Model 470036), a reusable surgical instrument. The recall addresses increased reports of frayed or broken grip cables in these instruments.
Grip cables are critical to instrument operation during surgery. When frayed or broken, the forceps may not function properly, potentially compromising surgical performance. The affected batches were manufactured between 2023 and 2024.
The recalled units have been distributed across the United States and internationally to over 40 countries. Affected instruments can be identified by their batch numbers and UDI-DI codes provided in recall notices from the manufacturer.
The recalled product
- Product
- 8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- cable-failure
- instrument-malfunction
Distribution
Distribution scope not specified by the agency.
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