Z-1335-2014Class II

5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive...

Name: Z-1335-2014 5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive...
Creator: Intuitive Surgical, Inc.
Published: 2014-03-13
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2014-03-13 / Terminated / root cause: design

FDA source

Intuitive Surgical, Inc. began a recall of 5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The... on 2014-03-13. FDA classified it as Class II and gives the reason as "Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1335-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-13
Posted: 2014-04-04
Terminated: 2014-09-03
Recalling firm: Intuitive Surgical, Inc.
Product: 5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators,monopolar cautery, bipolar cautery, 5mm curved cannulae,5mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.
Root cause tag: design
FDA root cause: Device Design
Action: Intuitive sent an Urgent Medical Device letter dated March 25, 2014, to all users of cannulas that have the potential to be damaged during use as well as a second letter to all single site cannula users that provided clarity to instruction for use for inspections and handling of the product. Certain lots manufactured prior to August of 2012, and users were asked to use Attachment A to help identify affected lots numbers. Phase 1 - Cannulas should then be inspected with information provided in Attachment B. Any damaged devices should be quarantined and returned to intuitive. If inspection does not find damage, the device may continue to be used. Any other cannulae and any non damaged product should be used according to Attachment C's instructions for use. Phase 2 - Once replacement cannulae are available, the undamaged cannulae should be returned. The Acknowledgement form should be completed and returned to Intuitive. Intuitive will contact consignees when replacement cannulae are available. Questions should be directed to Customer Service at 800-876-1310. Those consignees that use the 5 mm canulae but do not have affected product were provided with a letter that only includes the Single Site Cannula inspection and Use addendum.
Quantity in commerce: 5217 total cannulae
Distribution: Worldwide Distribution - USA and the countries of Australia, Belgium, Brazil, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Lebanon, Monaco, Netherlands, Norway, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Product codes and lots: Part number 428072-03: Lot numbers: VE113001 VE121005 VE121204 VE121904 VE122404 VE123008 VE113402 VE121008 VE121406 VE121906 VE122607 VE123013 VE114002 VE121104 VE121507 VE122102 VE122706 VE114402 VE121106 VE121511 VE122103 VE122905 VE120603 VE121111 VE121609 VE122301 VE122909 VE120702 VE121203 VE121708 VE122402 VE122912.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1335-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1332-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-04
Z-1333-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-04
Z-1334-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-04
Z-1335-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-04

Product code NAY

K112208Class IIIntutive Surgical Da Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. / cleared 2011-12-08

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)