FDA-Device2026-04-08Class IIPROCESSING DEFECT
Intuitive Surgical da Vinci S/Si Mega Needle Driver recalled for broken grip cables
OTHERNationwide distribution
Stop using da Vinci Mega Needle Driver instruments
Intuitive Surgical has recalled certain da Vinci S and Si Mega Needle Driver surgical instruments due to complaints of broken or frayed grip cables. These cables transmit motion from the surgeon's controls to the instrument tip inside the patient. The issue affects specific batch numbers manufactured between 2010 and 2018.
- Check if your da Vinci Mega Needle Driver (Model 420194) batch number matches the recall list
- Stop using affected instruments immediately and set them aside
- Contact your Intuitive Surgical representative or the FDA for instructions on replacement or repair
- Review the complete batch numbers on the FDA website to confirm if your instruments are affected
Hazard
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Sold states
Worldwide - U.S. Nationwide distribution in the states of CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA and WI. The countries of Argentina, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
Affected count
7819
Manufactured in
1266 Kifer Rd, Sunnyvale, CA, United States
Products
Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1698-2026More Intuitive Surgical, Inc. recalls
- FDA-Device2026-04-08Intuitive Surgical da Vinci S/Si Cautery Hook instruments recalled for frayed or broken cables
- FDA-Device2026-04-08Intuitive Surgical da Vinci S/Si Grasping Retractor recalled for broken grip cables
- FDA-Device2026-04-08Intuitive Surgical da Vinci S and Si Monopolar Curved Scissors recalled for broken grip cables
- FDA-Device2026-04-08Intuitive Surgical da Vinci S, Si Double Fenestrated Grasper recalled for broken grip cables
- FDA-Device2026-04-08Intuitive Surgical da Vinci Tenaculum Forceps recalled for frayed or broken pitch cables
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