FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular, LLC: 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.
- Recall number
- Z-1593-2011
- 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.
- Status
- Terminated
- Initiated
- 2010-12-07
- Posted
- 2011-03-07
- Terminated
- 2012-09-12
- Reason
- One unit of Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch which did not meet the internal release criteria for water permeability was distributed.
- 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
- one unit
- Distribution
- Nationwide distribution: SC only.
- Lot, serial or model codes
- 510 k - K962342, Product Code/UP #M00202019579P0; Batch #25018564; Exp Date 7/31/2005
- 510(k) numbers
- ["K962342"]
- PMA numbers
- not on file
- Product code
- DSY
- Firm FEI
- 2242352
- Firm city
- Wayne
- Firm state
- NJ
- 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