8MM Maryland Bipolar Forceps Recalled for Frayed Grip Cable
Intuitive Surgical is recalling 68,458 units of its 8MM Maryland Bipolar Forceps due to increased complaints about frayed or broken grip cables on the reusable surgical instruments.
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 recall where the hazard (grip cable fraying or breaking) poses a risk of harm during surgical use. The source does not explicitly report any injuries or hospitalizations, making this a risk-of-harm product where injury has not yet been reported, consistent with a High severity rating.
Plain-English summary
Intuitive Surgical, Inc. is recalling 68,458 units of its 8MM Maryland Bipolar Forceps (Model 471172) surgical instruments due to increased complaints regarding frayed or broken grip cables. These reusable instruments are used in surgical procedures.
The affected instruments were distributed nationwide in the United States and internationally to multiple countries including Canada, Australia, Japan, the United Kingdom, and others, as specified in the FDA recall notice.
The grip cables on these forceps can fray or break, which may compromise proper function during surgical use. This is classified as an FDA Class II recall.
The recalled product
- Product
- 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- cable-failure
Distribution
Distribution scope not specified by the agency.
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