Intuitive Surgical Recalls Grip Cables on Mega Suturecut ND Surgical Instruments
Intuitive Surgical is recalling 8MM Mega Suturecut ND surgical instruments due to increased complaints of frayed or broken grip cables that may affect instrument operation.
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 with no reported patient injuries or hospitalizations documented in the source. However, the product is a surgical instrument where cable failure could affect proper operation during medical procedures, meeting the criterion for a risk-of-harm product without reported injury.
Plain-English summary
Intuitive Surgical, Inc. is recalling 8MM Mega Suturecut ND surgical instruments (Model 471309) due to increased complaints of frayed or broken grip cables on the reusable jawed instruments.
The grip cables control the jaws of the instrument. When frayed or broken, the cables may not operate as intended, which could affect the instrument's performance during use.
Approximately 88,840 units with affected batch numbers have been distributed throughout the United States and internationally. Healthcare facilities should stop using affected instruments and contact Intuitive Surgical for replacement or repair. Affected batches can be identified by UDI-DI code 00886874119815 and specific batch numbers listed in the recall notice.
The recalled product
- Product
- 8MM,MEGA SUTURECUT ND,IS4000 REF 471309
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 88,840
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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