Z-1009-04

Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt

Name: Z-1009-04 Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt
Creator: Cobe Cardiovascular, Inc
Published: 2004-05-25
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2004-05-25 / Terminated

FDA source

Cobe Cardiovascular, Inc began a recall of Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt on 2004-05-25. The reason FDA records is "Some Cardioplegia Delivery Sets, 4:1 w/shunt, were misassembled with 1:1 tubing sub-assemblies. This would provide 2 1/2x the desired cardioplegia". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1009-04
Status: Terminated
Initiated: 2004-05-25
Posted: 2004-07-20
Terminated: 2005-03-31
Recalling firm: LivaNova USA, Inc.
Product: Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt
Product code: DTN Reservoir, Blood, Cardiopulmonary Bypass
Reason for recall: Some Cardioplegia Delivery Sets, 4:1 w/shunt, were misassembled with 1:1 tubing sub-assemblies. This would provide 2 1/2x the desired cardioplegia.
FDA root cause: Other
Action: Customers were notified by telephone on 5/25/2004 and by letter on 6/3/2004.
Quantity in commerce: 216 sets
Distribution: AL, AZ, FL, KS, MN, MO, NV, TX, WI. Foreign distribution to Canada.
Product codes and lots: Catalog # 027770201, Lot # 0406800015.

Product code DTN

K934847Class IINgbcd & Ngbcdp Cardioplegia Delivery SystemsSorin Biomedical, Inc. / cleared 1994-04-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)