Edwards Lifesciences Research Medical, Inc. Thin-Flex Venous Return Cannulae, 33/43 FR. x 39 cm, REF TF3343O, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614 Intended for cannula drainage of the superior and inferior vena cava during extracorporeal circulation for a duration of less than and equal to 6 hours. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Thin-Flex Venous Return Cannulae, 33/43 FR. x 39 cm, REF TF3343O, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614 Intended for cannula drainage of the superior and inferior vena cava during extracorporeal circulation for a duration of less than and equal to 6 hours.
Brand
Edwards Lifesciences Research Medical, Inc.
Lot Codes / Batch Numbers
Lot Number 58449974
Products Sold
Lot Number 58449974
Edwards Lifesciences Research Medical, Inc. is recalling Thin-Flex Venous Return Cannulae, 33/43 FR. x 39 cm, REF TF3343O, Sterile EO, Edwards Lifesciences L due to Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.
Recommended Action
Per FDA guidance
All domestic consignees were notified by a Product Recall letter on 07/15/2008 via FedEx. They were instructed to check their inventory for any affected product and return all unused product from their stock to Edwards. Customers are to contact Customer Service Organization to obtain a Returned Goods Authorization number and replacement product. Once inventory has been verified, the attached form needs to be completed and faxed to Edwards so that customer awareness can be confirmed. International accounts were notified on 07/14/2008.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, LA, MI, MN, MS, MO, NC, ND, SC, TX, WA
Page updated: Jan 10, 2026