Intuitive Surgical recalled 2,095 units of the da Vinci S, Si EndoWrist Tenaculum Forceps Instrument distributed nationwide in the United States and in multiple countries after reports of frayed or broken pitch cables. The defect can compromise instrument control during surgery. Hospitals and surgeons should stop using the device immediately and follow recall instructions from Intuitive Surgical.
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical 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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EndoWrist instruments are reusable robotic surgical tools used with the da Vinci system to manipulate tissue during procedures. The Tenaculum Forceps Instrument is used for grasping and tissue manipulation.
Frayed or broken pitch cables can compromise the instrument’s motion transmission, reducing control during surgery and potentially causing tissue injury.
This recall is not presented as part of a broader standard pattern in this release.
Hospitals and surgeons may face equipment downtime, delayed surgeries, and potential safety risks if affected instruments are used.
Recall notice and instrument labels show model 420207 and lot code 420207; refer to Intuitive Surgical communications and FDA recall Z-1700-2026.
Replacement or refund timelines will be provided by Intuitive Surgical in their recall communications; typical timelines range weeks to months.
Keep the recall letter, serial and lot codes, date of purchase, and all correspondence with the manufacturer.
Brand: Intuitive Surgical Product: da Vinci S, Si EndoWrist Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Quantity recalled: 2,095 instruments Distribution: U.S. nationwide in AR, CA, CT, FL, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, NC, OH, PA, TX, VA, WA; Numerous listed countries Classification: Class II Hazard: Frayed or broken pitch cables that transmit motion from input discs to the distal tip Remedy: Stop using the device immediately. Follow recall instructions. Contact Intuitive Surgical or healthcare provider for instructions Recall site
No injuries or incidents have been reported.
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