CLASS II Device recall · Reported 20 Apr 2016 · FDA Enforcement Report
da Vinci S Surgical System (IS4000) user manual English and OUS recalled
Intuitive Surgical is recalling da Vinci S Surgical System (IS4000) user manual English and OUS, distributed nationwide in the US. The recall was initiated on 16 Mar 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1377-2016
- FDA event ID
- 73649
- Recalling firm
- Intuitive Surgical, Sunnyvale, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Mar 2016
- FDA classified
- 12 Apr 2016
- Reported
- 20 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Heart & Vascular Devices
Timeline
| 16 Mar 2016 | Recall initiated by company | |
| 12 Apr 2016 | Classified by FDA | +27 days |
| 20 Apr 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large Needle Driver Instrument) to manipulate the ablation probes during cardiac surgery can result in an increase of microscopic metallic particulates generated from the contact with the probes.
Product as listed by the FDA
da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Where it was distributed
Worldwide Distribution - US Nationwide in the countries Australia, Belgium, Brazil, Canada, Chile, Finland, France, Germany, Greece, Iceland, India, Israel, Italy, Netherlands, Qatar, Russia, Singapore, South Korea, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
Questions about this recall
Is da Vinci S Surgical System (IS4000) user manual English and OUS recalled?
Yes. Intuitive Surgical recalled da Vinci S Surgical System (IS4000) user manual English and OUS on 16 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-1377-2016.
Why was it recalled?
Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large Needle Driver Instrument) to manipulate the ablation probes during cardiac surgery can result in an increase of microscopic metallic particulates generated from the contact with the probes.
Which lots are affected?
Model number 551457- IS4000 English: Model number 551706 - IS4000 OUS
Where was it sold?
Worldwide Distribution - US Nationwide in the countries Australia, Belgium, Brazil, Canada, Chile, Finland, France, Germany, Greece, Iceland, India, Israel, Italy, Netherlands, Qatar, Russia, Singapore, South Korea, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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