Intuitive Surgical Bipolar Grasper Recall Due to Frayed or Broken Grip Cables
Intuitive Surgical is recalling 14,507 8MM Long Bipolar Graspers due to increased complaints of frayed or broken grip cables that could impair surgical control during laparoscopic procedures.
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: This is an FDA Class II recall of a surgical instrument with mechanical failure risk. No illnesses or injuries are reported in the source text, but the frayed or broken grip cables create a potential safety hazard during laparoscopic procedures. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Intuitive Surgical, Inc. is recalling the 8MM Long Bipolar Grasper (Model 471400, Part Number 471400-10) used in laparoscopic surgical procedures. A total of 14,507 units are affected and have been distributed nationwide across all U.S. states, Puerto Rico, and internationally.
The recall was initiated due to increased complaints regarding frayed or broken grip cables on the reusable surgical instrument. Grip cable failure could compromise the surgeon's ability to control the instrument effectively during procedures.
The affected batch numbers range from K10221106 through K11240702. Healthcare facilities that have received this model should verify their inventory against these batch numbers and consult with Intuitive Surgical regarding the affected instruments.
The recalled product
- Product
- 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 14,507
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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