Z-1593-2011

Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch Indicated for cardiac and vascular patch grafting...

Name: Z-1593-2011 Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch Indicated for cardiac and vascular patch grafting...
Creator: Maquet Cardiovascular, LLC
Published: 2010-12-07
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2010-12-07 / Terminated

FDA source

Maquet Cardiovascular, LLC began a recall of Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch Indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients... on 2010-12-07. The reason FDA records is "One unit of Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch which did not meet the internal release criteria for water permeability was distributed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1593-2011
Status: Terminated
Initiated: 2010-12-07
Posted: 2011-03-07
Terminated: 2012-09-12
Recalling firm: Maquet Cardiovascular LLC
Product: Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch Indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
Product code: DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Reason for recall: One unit of Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch which did not meet the internal release criteria for water permeability was distributed.
FDA root cause: Other
Action: The firm, Maquet, contacted their sole consignee/customer via telephone informing the customer of the recall and instructing the customer to put the unit to the side. On December 8, 2010 a sales representative visited the site to ensure the unit had been put to the side and to ensure the unit was shipped back to Maquet. If you have any questions, call the Manager, Regulator Affairs at 973-709-7487.
Quantity in commerce: one unit
Distribution: Nationwide distribution: SC only.
Product codes and lots: 510 k - K962342, Product Code/UP #M00202019579P0; Batch #25018564; Exp Date 7/31/2005

Product code DSY

K962342Class IIHemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchMeadox Medicals, Div. Boston Scientific Corp. / cleared 1996-09-10

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)