Fenestrated Graspers Recalled Due to Potential Breakage and Fragment Risk
Intuitive Surgical is recalling 46,033 da Vinci Xi/X Tip-Up Fenestrated Graspers worldwide due to a manufacturing issue that can cause grip breakage, potentially allowing stainless steel fragments to enter the patient.
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: FDA Class II recall of a surgical instrument with risk-of-harm potential from stainless steel fragments that could remain inside the patient. No injuries have been reported. Meets rubric criterion: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling 46,033 units of the da Vinci Xi/X Tip-Up Fenestrated Grasper (REF: 470347, VER: 12) due to a manufacturing defect affecting all lot numbers.
A manufacturing issue has the potential to cause breakage of both upper and lower grips. This could result in stainless steel fragments falling into the patient, which may or may not be detected during surgery. The recalled instruments were distributed worldwide, including throughout the United States and to numerous international locations.
Healthcare facilities and surgeons using these instruments should immediately discontinue use of the affected graspers. Contact Intuitive Surgical, Inc. for instructions on safe use, replacement, or return of the recalled units. Units may be identified using the provided UDI-DI code.
The recalled product
- Product
- da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- device-breakage
- internal-fragment-risk
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 (2)
- UDI-DI: 00886874112496
- All Lots.
Distribution
Distributed nationwide across the United States.
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