Edwards Lifesciences, LLC: Medical Device Recall in 2013 - (Recall #: Z-1963-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 30, 2013

Date Posted: August 21, 2013

Recall Number: Z-1963-2013

Event ID: 65838

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.

Status: Terminated

Product Quantity: 29,618 units

Code Information:

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 Pattern:

Nationwide and the country of Canada

Voluntary or Mandated:

Voluntary: Firm initiated