Recall Z-0614-2011 ยท GCJ Laparoscope, General & Plastic Surgery
CTS, Inc. dba Guidant Cardiac Surgery
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
| Date | Dec 13, 2010 (initiated Feb 5, 2009) |
| Status | Terminated |
| Reason | Sterility may be compromised by a loss of package integrity. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030512 | GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM Guidant Corp., May 14, 2003 |