Intuitive Surgical Recalls Cadiere Forceps for da Vinci Si System
Intuitive Surgical is recalling Cadiere Forceps used with the da Vinci Si Surgical System because the instrument jaws may become fixed in a closed position.
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: The recall involves a medical device defect that poses a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Intuitive Surgical, Inc. is recalling Cadiere Forceps (Model numbers 428055-12 and 428055-13) used with the da Vinci Si Surgical System (IS3000). The recall involves 2,410 units distributed worldwide, including the United States and various international locations.
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 endoscopic manipulation of tissue during surgical procedures.
Healthcare facilities and users should stop using the affected instruments and contact Intuitive Surgical for further instructions on the recall process.
The recalled product
- Product
- Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428055-12, 428055-13. 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 physicians in
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 2,410
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: 428055-12
- 428055-13..
- 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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