EndoWrist Stapler 45 instrument for the da Vinci Si System Model… — Class II medical device recall Z-0074-2015
Terminated recall by Intuitive Surgical, Inc., reported 2014-10-22, distributed nationwide. Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due
| Recall number | Z-0074-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2014-09-18 |
| Classified | 2014-10-16 |
| Reported by FDA | 2014-10-22 |
| Terminated | 2015-03-03 |
| Distributed | Nationwide (US) |
| Quantity | 1,034 devices |
| Model numbers | 410298-06, IS3000 |
Product
EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System 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, electrocautery and accessories 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, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, 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 (except for transoral otolaryngology surgical procedures). 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.
Reason for recall
Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due to reports of inability to remove the stapler from tissue.
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.