The Recall Desk
HighFDA (Devices)·Z-0882-2025·Announced 2025-01-22

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.

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 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.
Category
Medical Device — Surgical Instruments / Laparoscopic
Hazard
  • mechanical-failure
  • grip-loss

Distribution

Distribution scope not specified by the agency.

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