Guidant Cardiac Surgery Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button.
Brand
Guidant Cardiac Surgery
Lot Codes / Batch Numbers
HSK-2038, HSK-2043. All lots are affected by this recall.
Products Sold
HSK-2038, HSK-2043. All lots are affected by this recall.
Guidant Cardiac Surgery is recalling Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and a due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, MO, NE, OK
Page updated: Jan 10, 2026