Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch recallZ-1593-2011 · Maquet Cardiovascular, LLC · initiated Dec 7, 2010
Terminated All recalls posted in March 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Cardiovascular, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1593-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 7, 2010
- Posted by the FDA
- Mar 7, 2011
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- one unit
- Product code
- DSY
- FDA submissions
- K962342
- Distribution
- Nationwide distribution: SC only.
Product description
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.
Code information (models, lots, serial numbers)
510 k - K962342, Product Code/UP #M00202019579P0; Batch #25018564; Exp Date 7/31/2005
Other devices under the same FDA submission
1 device cleared under K962342 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Hemashield M00202019579P0Intervascular Sas · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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