FDA Medical Device Recalls (openFDA)
Guidant Cardiac Surgery: Guidant Brand VasoView 5 Harvesting Cannula System, Model Number: VH-1000
- Recall number
- Z-0292-04
- Recalling firm
- Guidant Cardiac Surgery
- Product
- Guidant Brand VasoView 5 Harvesting Cannula System, Model Number: VH-1000
- Status
- Terminated
- Initiated
- 2003-11-19
- Posted
- 2004-07-20
- Terminated
- 2004-03-09
- Reason
- VasoView 5 scissors are stiff and/or the scissor toggle has the potential to break during use.
- Root cause
- Nonconforming Material/Component
- Action
- On 11/19/03, the firm issued letters via FedEx to all its direct consignees, informing them of the affected devices and providing instructions on the recall.
- Quantity
- 2597 units
- Distribution
- There are a total of 130 consignees that received the recalled product distributed by Guidant. The firm has identified 0 (zero) wholesaler dealers, 7 distributors or affiliate companies, 0 (zero) retailers and 123 hospitals that received the recalled product distributed by Guidant. The recalled product was distributed in the United States and internationally. Recalled product was distributed by the firm to one (1) government account: USAF Medical Center Keesler, 1301 I Street, Keesler Air Force Base, MS 39534, (228) 377-2778. International countries include: Puerto Rico, Belgium, Chile, France, Germany, Italy and Kuwait.
- Lot, serial or model codes
- Lot-- Exp Date: 3081371-- 7/2004, 3081471-- 7/2004, 3081571-- 7/2004, 3081871-- 7/2004, 3081972-- 7/2004, 3082071-- 7/2004, 3082171-- 7/2004, 3082271-- 7/2004, 3082272-- 7/2004, 3082571-- 7/2004, 3082671-- 7/2004, 3082772-- 7/2004, 3082871-- 7/2004, 3082972-- 7/2004, 3090271-- 8/2004, 3090371-- 8/2004, 3090471-- 8/2004, 3090571-- 8/2004, 3090871-- 8/2004, 3090971-- 8/2004, 3091072-- 8/2004, 3091171-- 8/2004, 3091271-- 8/2004, 3091571-- 8/2004, 3091671-- 8/2004, 3091771-- 8/2004, 3091871-- 8/2004, 3091971-- 8/2004, 3092271-- 8/2004, 3092372-- 8/2004, 3092471-- 8/2004, 3092571-- 8/2004, 3092671-- 8/2004, 3100271-- 9/2004
- 510(k) numbers
- ["K020143"]
- PMA numbers
- not on file
- Product code
- HET
- Firm FEI
- 3000719698
- Firm city
- Santa Clara
- Firm state
- CA
- 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