Cobe Cardiovascular, Inc Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt.
Brand
Cobe Cardiovascular, Inc
Lot Codes / Batch Numbers
Catalog # 027819201, Lot Number 0304300106.
Products Sold
Catalog # 027819201, Lot Number 0304300106.
Cobe Cardiovascular, Inc is recalling Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt. due to Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size.
Recommended Action
Per FDA guidance
All consignees were contacted by telephone on 05/09/2003, followed by a letter.
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
MN, NE, OK
Page updated: Jan 10, 2026