Z-0476-2009

VASOVIEW 4 Endoscopic Vessel Harvesting System, with VASOVIEW Flexible Endoscopic Tools in the following...

Name: Z-0476-2009 VASOVIEW 4 Endoscopic Vessel Harvesting System, with VASOVIEW Flexible Endoscopic Tools in the following...
Creator: CTS, Inc. dba Guidant Cardiac Surgery
Published: 2008-09-09
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2008-09-09 / Terminated / root cause: packaging

FDA source

CTS, Inc. dba Guidant Cardiac Surgery began a recall of VASOVIEW 4 Endoscopic Vessel Harvesting System, with VASOVIEW Flexible Endoscopic Tools in the following configurations: VH-10242: Uniport plus dissection... on 2008-09-09. The reason FDA records is "Packaging unsealed: Sterility of product may be compromised due to packaging issue. For further information, please contact the firm at 408-635-6874". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0476-2009
Status: Terminated
Initiated: 2008-09-09
Posted: 2008-12-23
Terminated: 2010-12-08
Recalling firm: Maquet Cardiovascular LLC
Product: VASOVIEW 4 Endoscopic Vessel Harvesting System, with VASOVIEW Flexible Endoscopic Tools in the following configurations: VH-10242: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic scissors; and VH-10243: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic bisector.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Packaging unsealed: Sterility of product may be compromised due to packaging issue. For further information, please contact the firm at 408-635-6874.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm issued a letter entitled "URGENT FIELD ACTION - IMMEDIATE ACTION REQUIRED *** VASOVIEW(TM) 4 Endoscopic Vessel Harvesting System (Kit Only)" via federal express to its consignees on September 9, 2008. The firm has asked its consignees to return the product. Follow-up calls were made to ensure recall effectiveness.
Quantity in commerce: 7,935 units
Distribution: Worldwide Distribution --- including USA and country of Australia.
Product codes and lots: model numbers VH-10242, lot numbers 7100172 to 8081371, and VH-10243, lot numbers 7100171 to 8081271.

Product code GCJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)