Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button.
- Company
- Guidant Cardiac Surgery
- Recall Initiated
- July 5, 2005
- Posted
- August 24, 2005
- Terminated
- January 9, 2006
- Recall Number
- Z-1396-05
- Quantity
- 7391 units
- Firm Location
- Santa Clara, CA
Reason for Recall
Incomplete or no aortotomy may occur with use of the aortic cutter on unaltered tissue, or incomplete aortotomy may result when the cutter is used on altered tissue. Use of the cutter on altered tissue has caused the aortic plug to not be captured by the device
Distribution
Product was distributed to 274 consignees. 15 are international distributors. 259 hospitals. The product is fully distributed to the following countries: USA, Belgium, CAnada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Israel, Italy, Lebanon, Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, and Swizerland. 3 VAs received product: 13000 Bruce B Downs Blvd, Tampla, FL, 800 Hospital Dr., columbia, MO, and 921 NE 13th st., Oklahoma City, OK.
Lot / Code Info
HSK-2038, HSK-2043. All lots are affected by this recall.
Root Cause
Other
Action Taken
Notification to customers sent via FedEx on July 5, 2005, with product handling instruction sheet. Follow up communications to non-returning consignees will be recorded and documented.