Assembly — Class II medical device recall Z-0436-2014
Terminated recall by Intuitive Surgical, Inc., reported 2013-12-11, distributed nationwide. Reports of friction within certain instrument arms can interrupt smooth instrument motion. This can be felt by
| Recall number | Z-0436-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2013-11-11 |
| Classified | 2013-12-03 |
| Reported by FDA | 2013-12-11 |
| Terminated | 2014-02-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BG, BR, CA, CH, CN, DE, DK, ES, FR, GB, IL, IN, IT, JP, KR, LU, MX, NL, NO, RO, SE, SG, TH, TR, TW |
| Quantity | 1,386 |
| Model numbers | 380900-02, 380900-03, IS2000/3000 |
Product
Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System; da Vinci SI Surgical System da Vinci Si-e Surgical System; Manufactured by Intuitive Surgical Sunnyvale, CA 94086. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS2000/3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electro cautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electro cautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general cardiovascular and non-cardiovascular thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system is indicated for adult and pediatric use
Reason for recall
Reports of friction within certain instrument arms can interrupt smooth instrument motion. This can be felt by the surgeon as resistance in the movement of the master.In this situation, the instrument can stall momentarily and then suddenly catch-up to the master position if the surgeon pushes through the resistance.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.