Intuitive Surgical Recalls da Vinci Xi EndoWrist Stapler 45 Instruments
Intuitive Surgical is recalling 60 da Vinci Xi EndoWrist Stapler 45 instruments due to a manufacturing variation that may prevent the release wrench from unclamping the device.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a functional defect that may prevent manual unclamping of the instrument, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Intuitive Surgical, Inc. is recalling 60 units of the da Vinci Xi EndoWrist Stapler 45 (REF 470298) distributed nationwide in the United States. The recall is due to a variation in the manufacturing process that affects the Stapler Release Kit (SRK) Wrench interface feature accessed through release hole 2.
In the affected instruments, this interface feature may be manufactured to an incorrect dimension. This defect may prevent the SRK Wrench from being able to manually unclamp the instrument. The device is intended for use with the da Vinci Surgical System for resection, transection, and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery.
Healthcare providers should check their inventory for the specific serial numbers listed in the recall notice: S10170630, S11170705, S10170707, and S10170731. Affected units should be removed from service and returned to Intuitive Surgical for evaluation and replacement.
The recalled product
- Product
- daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for…
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 60
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 (4)
- UDI 00886874112427: Serial Numbers: S10170630
- S11170705
- S10170707
- S10170731
Distribution
Distributed nationwide across the United States.
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