Z-0292-04

Guidant Brand VasoView 5 Harvesting Cannula System, Model Number: VH-1000

Name: Z-0292-04 Guidant Brand VasoView 5 Harvesting Cannula System, Model Number: VH-1000
Creator: Guidant Cardiac Surgery
Published: 2003-11-19
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2003-11-19 / Terminated / root cause: manufacturing process

FDA source

Guidant Cardiac Surgery began a recall of Guidant Brand VasoView 5 Harvesting Cannula System, Model Number: VH-1000 on 2003-11-19. The reason FDA records is "VasoView 5 scissors are stiff and/or the scissor toggle has the potential to break during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0292-04
Status: Terminated
Initiated: 2003-11-19
Posted: 2004-07-20
Terminated: 2004-03-09
Recalling firm: Maquet Cardiovascular LLC
Product: Guidant Brand VasoView 5 Harvesting Cannula System, Model Number: VH-1000
Product code: HET Laparoscope, Gynecologic (And Accessories)
Reason for recall: VasoView 5 scissors are stiff and/or the scissor toggle has the potential to break during use.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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

Product code HET

K020143Class IIVasoview 5 Harvesting CannulaGuidant Corporation, Cardiac Surgery / cleared 2002-02-20

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)