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device recall
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Intuitive Surgical, Inc. device recall (Cls II)

December 9, 2025$ISRGupdated 6mo ago
community read0 votes

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 — Reason: Due to increased complaints for broken/frayed grip cables for reusable instruments. — Status: Ongoing

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same company · ±60 days · 6

  • device recallIntuitive Surgical, Inc. device recall (Cls II)Dec 9, 2025
  • device recallIntuitive Surgical, Inc. device recall (Cls II)Dec 9, 2025
  • device recallIntuitive Surgical, Inc. device recall (Cls II)Dec 9, 2025
  • device recallIntuitive Surgical, Inc. device recall (Cls II)Dec 9, 2025
  • device recallIntuitive Surgical, Inc. device recall (Cls II)Dec 9, 2025
  • device recallIntuitive Surgical, Inc. device recall (Cls II)Dec 4, 2025

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