Z-0614-2011

Heartstring II Proximal Seal / VASOVIEW 6 Endoscopic Vessel Harvesting System, Model Number: VH-2000, Product...

Name: Z-0614-2011 Heartstring II Proximal Seal / VASOVIEW 6 Endoscopic Vessel Harvesting System, Model Number: VH-2000, Product...
Creator: CTS, Inc. dba Guidant Cardiac Surgery
Published: 2009-02-05
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2009-02-05 / Terminated / root cause: packaging

FDA source

CTS, Inc. dba Guidant Cardiac Surgery began a recall of Heartstring II Proximal Seal / VASOVIEW 6 Endoscopic Vessel Harvesting System, Model Number: VH-2000, Product is manufactured and distributed by Maquet... on 2009-02-05. The reason FDA records is "Sterility may be compromised by a loss of package integrity". 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-0614-2011
Status: Terminated
Initiated: 2009-02-05
Posted: 2010-12-13
Terminated: 2011-01-19
Recalling firm: Maquet Cardiovascular LLC
Product: Heartstring II Proximal Seal / VASOVIEW 6 Endoscopic Vessel Harvesting System, Model Number: VH-2000, Product is manufactured and distributed by Maquet Corporation San Jose, CA
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Sterility may be compromised by a loss of package integrity.
Root cause tag: packaging
FDA root cause: Packaging
Action: Maquet issued an Urgent Device Removal letter dated February 5, 2009 to customers, explaining the reason for the recall and requesting the product be returned for replacement. Customers were instructed to examine their inventory and discontinue distribution and use of the affected devices. Customers also were requested to complete and return a Field Action Response Form. Maquet can be contacted at 888-880-2874 concerning this recall.
Distribution: Distribution: Nationwide and Internationally.
Product codes and lots: Affected Lot Number Range: 8030373 to 8112071

Product code GCJ

K030512Class IIGuidant Vasoview Endoscopic Vessel Harvesting SystemGuidant Corp. / cleared 2003-05-14

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)