Intuitive Surgical Recalls Mega Needle Drivers for Potential Jaw Detachment
Intuitive Surgical is recalling Mega Needle Drivers for the da Vinci S and Si systems due to a potential risk of jaw insert detachment.
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 defect in a surgical instrument that poses a risk of harm during a procedure, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling Mega Needle Driver, 8MM assemblies used with the da Vinci S IS1200 and da Vinci Si IS2000 systems. The recall involves approximately 11,235 units that were distributed nationwide in the United States, including Puerto Rico, as well as internationally to multiple countries in Europe and Asia.
The recall was initiated because the firm became aware of the potential for detachment of the jaw insert on these instruments. The Mega Needle Driver is part of the EndoWrist instrument family intended for endoscopic manipulation and suturing of tissue. The specific hazard identified is the potential mechanical failure of the jaw insert during use.
The recalled product
- Product
- Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation…
- Manufacturer
- Intuitive Surgical, Inc.
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 (1)
- Part number 400194 on da Vinci IS1200
Distribution
Part of a larger recall action
This product is one of 2 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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