Intuitive Surgical Recalls Curved Needle Drivers for da Vinci System
Intuitive Surgical is recalling 3,698 Curved Needle Drivers used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.
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: The recall is classified as FDA Class II, and the hazard involves a mechanical failure in a surgical instrument where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Intuitive Surgical, Inc. is recalling 3,698 Curved Needle Drivers (Model numbers 428088-12 and 428088-13) used with the da Vinci Si Surgical System (IS3000). The recall covers all lots of these specific instruments.
The recall was initiated because, in certain circumstances, the jaws of these grip actuated instruments may become fixed in a closed position. This defect could potentially interfere with the intended surgical procedures for which the instruments are indicated.
The affected instruments were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Australia, Belgium, Brazil, Canada, and the United Kingdom. These instruments are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue during single incision laparoscopic cholecystectomy.
The recalled product
- Product
- Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428088-12, 428088-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained…
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 3,698
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model numbers: 428088-12
- 428088-13
- all lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 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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