Recall Z-1226-2015 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to stabilize the epicardial surface of the non-arrested heart during coronary art
| Date | Feb 27, 2015 (initiated Feb 16, 2015) |
| Status | Terminated |
| Reason | There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterility of the pouches outer surface. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Recall letters were sent on February 16, 2015 |
| Quantity | 706 units |
| Distribution | US and Belgium, Brazil, Canada, China, Finland, France, Greece, India, Italy, Japan, Qatar, Russia, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Turkey, United Kingdom |
| FDA record | Open on fda.gov |