FDA Device recall Z-1335-2014
5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000
- FDA Device
- Class II
- terminated
- Published 2014-04-16
On 2014-04-16 the FDA classified a Class II recall of 5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000 by Intuitive Surgical, citing 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 upd….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1335-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-13 |
| Published | 2014-04-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | n/a |
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.
Reason
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.
Identifiers
| code_info | Part number 428072-03: Lot numbers: VE113001 VE121005 VE121204 VE121904 VE122404 VE123008 VE113402 VE121008…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1335-2014%22
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