FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular, LLC: Hemashield Platinum Woven Double Velour TAAA Vascular Grafts.
- Recall number
- Z-2065-2010
- Recalling firm
- Maquet Cardiovascular, LLC
- Product
- Hemashield Platinum Woven Double Velour TAAA Vascular Grafts.
- Status
- Terminated
- Initiated
- 2010-05-24
- Posted
- 2010-07-22
- Terminated
- 2011-07-14
- Reason
- Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially compromise patient safety.
- Root cause
- Package design/selection
- Action
- Letters were sent by Federal Express commencing July 12, 2010. Distribution has to be obtained from Boston Scientific. Questions are directed to the local Sales/Service Representative, or to the firm's Customer Service at 1-888-880-2874.
- Quantity
- xx
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- xxx
- 510(k) numbers
- ["K052302"]
- PMA numbers
- not on file
- Product code
- MAL
- 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