Intuitive Surgical recalled 2,660 da Vinci S/Si Grasping Retractor Instruments worldwide after increased complaints of broken or frayed grip cables. The devices transmit motion from input disks to the distal tip and are used in robotic surgery. Hospitals and surgical centers should stop using the device immediately and follow recall instructions from the manufacturer.
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Intuitive Surgical, Inc. or your healthcare provider for instructions. Notification method: Letter
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The da Vinci S/Si EndoWrist instruments are reusable surgical tools used for endoscopic manipulation, including grasping, dissection, suturing, and delivery of ablation probes. They rely on tungsten cables and pulleys to transmit motion from the input discs to the distal tip.
Wear or breakage of grip cables can compromise instrument control and ergonomics during procedures, potentially impacting patient safety.
This recall is not described as part of a broader industry pattern in the provided data.
Hospitals may need to quarantine affected instruments, adjust inventory, and coordinate with Intuitive for replacements. The recall could affect surgical schedules and equipment availability.
Recall notices are available through the FDA enforcement page and the manufacturer’s recall communications.
Typically 4-8 weeks for replacement or remediation once processed by the manufacturer and hospital procurement channels.
Keep the recall notice, serial and batch numbers, purchase records, and correspondence with the manufacturer. Photograph labels and packaging for audit trails.
Model/Catalog Number: 420278; Brand: Intuitive Surgical; Product: da Vinci S, Si Grasping Retractor Instrument; Recall Date: 2025-12-09; Status: ACTIVE; Quantity: 2660; Distribution: Worldwide. U.S. statewide distribution includes CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA, WI. Additional countries include 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,
No injuries or incidents have been reported.
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