FDA Device recall Z-1332-2014
5X300 MM Curved Cannula, Arm 1 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 1 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-1332-2014 |
| 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 1 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 428061-03: Lot numbers: VE105001 VE120201 VE121301 VE121803 VE122502 VE123106 VE105002 VE120301 VE…Part number 428061-03: Lot numbers: VE105001 VE120201 VE121301 VE121803 VE122502 VE123106 VE105002 VE120301 VE121304 VE121907 VE122605 VE111201 VE120503 VE121403 VE122002 VE122606 VE114501 VE120703 VE121508 VE122101 VE122902 VE114601 VE121002 VE121605 VE122203 VE123006 VE115201 VE121112 VE121701 VE122401 VE123104. |
|---|
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-1332-2014%22
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