Z-1226-2015Class II

Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number...

Name: Z-1226-2015 Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number...
Creator: Intuitive Surgical, Inc.
Published: 2015-02-16
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2015-02-16 / Terminated / root cause: packaging

FDA source

Intuitive Surgical, Inc. began a recall of Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist... on 2015-02-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1226-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-16
Posted: 2015-02-27
Terminated: 2015-07-01
Recalling firm: Intuitive Surgical, Inc.
Product: 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 artery surgery.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: 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 tag: packaging
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Recall letters were sent on February 16, 2015
Quantity in commerce: 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
Product codes and lots: all PN 410187-05

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1226-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1226-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-02-27

Product code NAY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)