FDA Medical Device Recalls (openFDA)
Guidant Cardiac Surgery: Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button.
- Recall number
- Z-1396-05
- Recalling firm
- Guidant Cardiac Surgery
- Product
- Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button.
- Status
- Terminated
- Initiated
- 2005-07-05
- Posted
- 2005-08-24
- Terminated
- 2006-01-09
- Reason
- 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
- Root cause
- Other
- Action
- 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.
- Quantity
- 7391 units
- 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, serial or model codes
- HSK-2038, HSK-2043. All lots are affected by this recall.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 3000719698
- Firm city
- Santa Clara
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28