FDA Device recall Z-1333-2014
5X300 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 5X300 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-1333-2014 |
| 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
5X300 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 428062-03: Lot numbers: VE105003 VE120304 VE121402 VE121903 VE122704 VE123101 VE111202 VE120402…Part number 428062-03: Lot numbers: VE105003 VE120304 VE121402 VE121903 VE122704 VE123101 VE111202 VE120402 VE121502 VE121905 VE122705 VE123103 VE114502 VE120504 VE121506 VE122201 VE122707 VE123105 VE114602 VE120902 VE121512 VE122202 VE122903 VE115202 VE121003 VE121606 VE122303 VE123005 VE120202 VE121113 VE121702 VE122501 VE123012. |
|---|
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-1333-2014%22
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