Z-0960-03

Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt

Name: Z-0960-03 Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt
Creator: Cobe Cardiovascular, Inc
Published: 2003-05-09
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2003-05-09 / Terminated / root cause: labeling and UDI

FDA source

Cobe Cardiovascular, Inc began a recall of Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt on 2003-05-09. The reason FDA records is "Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0960-03
Status: Terminated
Initiated: 2003-05-09
Posted: 2003-07-02
Terminated: 2003-07-08
Recalling firm: LivaNova USA, Inc.
Product: Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt.
Product code: DTN Reservoir, Blood, Cardiopulmonary Bypass
Reason for recall: Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: All consignees were contacted by telephone on 05/09/2003, followed by a letter.
Quantity in commerce: 60 units
Distribution: MN, NE, OK
Product codes and lots: Catalog # 027819201, Lot Number 0304300106.

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)