FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular, LLC: EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm: L: 50 mm straight Maquet Cardiovascular LLS, 45 Barbour Pond Drive, Wayne, NJ 07470
- Recall number
- Z-0866-2010
- Recalling firm
- Maquet Cardiovascular, LLC
- Product
- EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm: L: 50 mm straight Maquet Cardiovascular LLS, 45 Barbour Pond Drive, Wayne, NJ 07470
- Status
- Terminated
- Initiated
- 2010-01-20
- Posted
- 2010-02-26
- Terminated
- 2010-07-06
- Reason
- Labeling mix up: Shelf Carton label for Exxcel Soft Thin Wall Vascular Grafts, lot # 12633379 were mislabeled as Exxcel Soft Standard Wall Grafts. Bleeding could occur if wrong product is used.
- Root cause
- Labeling mix-ups
- Action
- Recall letters were sent to all US customers on January 20, 2010 by certified mail. Letters for foreign consignees were to be sent as soon as translation was completed. Customer are directed to call the company at 973-709-7515 for more information.
- Quantity
- 18 units
- Distribution
- Product was distributed to hospitals in TX, TN, CT, AR, AZ as well as to Austria and France.
- Lot, serial or model codes
- Product Code: M002004910580; Lot # 12633379, Exp: 4/2012
- 510(k) numbers
- ["K052964"]
- 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