FDA Device recall Z-1963-2013
Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and…
- FDA Device
- Class II
- terminated
- Published 2013-08-21
On 2013-08-21 the FDA classified a Class II recall of Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and… by Edwards Lifesciences, citing edwards Lifesciences is recalling certain lots of the Anastaflo intravascular Shunt due to concerns of excessive adhesive on the shunt body that may interfere with suturing of by-….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1963-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-30 |
| Published | 2013-08-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Edwards Lifesciences |
| Distribution | US |
Product
Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25 Anastaflo shunts are intended for use in preventing ischemia by shunting and/ or perfusing blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts30.
Reason
Edwards Lifesciences is recalling certain lots of the Anastaflo intravascular Shunt due to concerns of excessive adhesive on the shunt body that may interfere with suturing of by-pass grafts.
Identifiers
| code_info | Model: IVS12512 Lots 58969460 to 59509355, Model: IVS1512 Lots 58914820 to 59518788, Model: IVS1530 Lots 58911395 to 59…Model: IVS12512 Lots 58969460 to 59509355, Model: IVS1512 Lots 58914820 to 59518788, Model: IVS1530 Lots 58911395 to 59473506, Model: IVS17512 Lots 58903206 to 59546227, Model: IVS2012 Lots 58911394 to 59531271, Model: IVS2030 Lots 58932183 to 59504235, Model: IVS2512 Lots 58914819 to 59518801, Model: IVS2530 Lots 58919317 to 59463362, Model: IVS3012 Lots 58966707 to 59514116 |
|---|
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-1963-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.