Intuitive Surgical Clip Applier Recalled for Frayed or Broken Grip Cables
Intuitive Surgical is recalling 5,576 units of the 8MM Horizon Small Clip Applier due to complaints of frayed or broken grip cables on the reusable instruments.
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: Class II recall with no reported injuries or hospitalizations. Grip cable failures on a surgical instrument represent a risk-of-harm defect without reported injury, meeting the High (3) severity criterion.
Plain-English summary
Intuitive Surgical, Inc. is recalling 5,576 units of the 8MM Horizon Small Clip Applier (Model 470401) distributed nationwide in the United States and internationally. The reusable surgical instrument comes in two part numbers: 470401-07 and 470401-08.
The manufacturer received increased complaints regarding frayed or broken grip cables on the instrument jaws. Multiple batch numbers manufactured between 2023 and 2024 are affected, including batch numbers K10230129 through K11240112.
Healthcare facilities and providers using affected devices should identify units by batch number and contact Intuitive Surgical, Inc. for instructions regarding handling of recalled devices.
The recalled product
- Product
- 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 5,576
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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