Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button.
Hazard
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
What You Should Do
Remedy
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.
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Products
Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button.
- Brand
- Guidant Cardiac Surgery
- UPC
- HSK-2038, HSK-2043. All lots are affected by this recall.
Units Affected
7391 units