FDA Medical Device Recalls (openFDA)
Cobe Cardiovascular, Inc: Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt.
- Recall number
- Z-0960-03
- Recalling firm
- Cobe Cardiovascular, Inc
- Product
- Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt.
- Status
- Terminated
- Initiated
- 2003-05-09
- Posted
- 2003-07-02
- Terminated
- 2003-07-08
- Reason
- Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size.
- Root cause
- Other
- Action
- All consignees were contacted by telephone on 05/09/2003, followed by a letter.
- Quantity
- 60 units
- Distribution
- MN, NE, OK
- Lot, serial or model codes
- Catalog # 027819201, Lot Number 0304300106.
- 510(k) numbers
- ["K934847"]
- PMA numbers
- not on file
- Product code
- DTN
- Firm FEI
- 1718850
- Firm city
- Arvada
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28