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Terminated

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

FDA Recall Z-0614-2011 · Posted 2010-12-13

Recalling FirmCTS, Inc. dba Guidant Cardiac Surgery
Recall StatusTerminated
Product CodeGCJ
Date Initiated2009-02-05
Date Terminated2011-01-19

Reason for Recall

Sterility may be compromised by a loss of package integrity.

Firm 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.

Root Cause

Packaging

Distribution Pattern

Distribution: Nationwide and Internationally.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030512GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEMGuidant Corp. · 2003-05-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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