Edwards Lifesciences Recalls Anastaflo Intravascular Shunts Due to Adhesive Concerns
Edwards Lifesciences is recalling specific lots of Anastaflo intravascular shunts because excessive adhesive on the shunt body may interfere with suturing during bypass graft construction.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect (excessive adhesive) may interfere with a critical surgical procedure (suturing), representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Edwards Lifesciences, LLC is recalling certain lots of the Anastaflo intravascular Shunt. The affected products include model codes IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030, and IVS2530. The recall covers 29,618 units distributed nationwide and in Canada.
The recall is being conducted due to concerns that excessive adhesive on the shunt body may interfere with the suturing of bypass grafts. These 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 grafts.
Healthcare facilities and distributors should stop using the affected lots and contact Edwards Lifesciences for further instructions. The specific lot numbers affected are listed in the agency's recall record Z-1963-2013.
The recalled product
- 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
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Cardiovascular
- Affected units
- 29,618
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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
Distribution
Distributed nationwide across the United States.
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