Fenestrated Bipolar Forceps Recalled Due to Frayed or Broken Grip Cables
Intuitive Surgical is recalling 147,006 units of 8MM Fenestrated Bipolar Forceps due to increased complaints of frayed or broken grip cables, which could impair surgical control.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 for a surgical instrument where grip cable failure presents a risk of harm during surgical use. No hospitalizations or injuries have been reported, but the potential for patient impact during surgery warrants high severity classification.
Plain-English summary
Intuitive Surgical, Inc. is recalling approximately 147,006 units of 8MM Fenestrated Bipolar Forceps (Model 471205, Part Number 471205-17) nationwide and internationally.
The forceps are subject to increased complaints of frayed or broken grip cables on the reusable instruments. Grip cable failure could impair a surgeon's ability to control the instrument during surgery, potentially affecting patient safety and surgical outcomes.
These devices have been distributed throughout the United States and to 60+ countries worldwide. The affected units are identified by multiple batch numbers provided by the manufacturer.
Healthcare facilities and practitioners who use these forceps should immediately cease use of affected units and inspect their instruments for visible cable fraying or breakage. Affected customers should contact Intuitive Surgical, Inc. for instructions on how to return or replace the affected devices.
The recalled product
- Product
- 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 147,006
Distribution
Part of a larger recall action
This product is one of 37 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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