Edwards Lifesciences Research Medical, Inc. Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm Edwards Lifesciences Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm Edwards Lifesciences
Brand
Edwards Lifesciences Research Medical, Inc.
Lot Codes / Batch Numbers
REF: A3221190A. Lot Number 58194673
Products Sold
REF: A3221190A. Lot Number 58194673
Edwards Lifesciences Research Medical, Inc. is recalling Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm Edwards Lifesciences due to Due to potential embrittlement of the plastic tip which may crack or separate during use.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to potential embrittlement of the plastic tip which may crack or separate during use.
Recommended Action
Per FDA guidance
Consignees were notified by letter and visit beginning 04/18/2006.
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
CA, CT, FL, IN, KS, MA, MI, OR, TN, TX
Page updated: Jan 10, 2026