Z-1396-05

Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation...

Name: Z-1396-05 Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation...
Creator: Guidant Cardiac Surgery
Published: 2005-07-05
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2005-07-05 / Terminated

FDA source

Guidant Cardiac Surgery began a recall of Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button on 2005-07-05. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1396-05
Status: Terminated
Initiated: 2005-07-05
Posted: 2005-08-24
Terminated: 2006-01-09
Recalling firm: Maquet Cardiovascular LLC
Product: Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button.
Product code: DYB Introducer, Catheter
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
FDA 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 in commerce: 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.
Product codes and lots: HSK-2038, HSK-2043. All lots are affected by this recall.

Product code DYB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)