Edwards Lifesciences Anastaflo Intravascular Shunt — Class II medical device recall Z-1963-2013
Terminated recall by Edwards Lifesciences, LLC, reported 2013-08-21, distributed nationwide. Edwards Lifesciences is recalling certain lots of the Anastaflo intravascular Shunt due to concerns of excessi
| Recall number | Z-1963-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Draper, UT, United States |
| Recall initiated | 2013-07-30 |
| Classified | 2013-08-14 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2014-10-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 29,618 units |
| Lot numbers | 58903206, 58911394, 58911395, 58914819, 58914820, 58919317, 58932183, 58966707, 58969460, 59463362, 59473506, 59504235, 59509355, 59514116, 59518788, 59518801, 59531271, 59546227 |
| Model numbers | 58903206, 58911394, 58911395, 58914819, 58914820, 58919317, 58932183, 58966707, 58969460, 59463362, 59473506, 59504235, 59509355, 59514116, 59518788, 59518801, 59531271, 59546227, IVS12512, IVS1512, IVS1530, IVS17512, IVS2012, IVS2030, IVS25 and 3 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1963-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.