Z-0866-2010

EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm: L: 50 mm straight Maquet Cardiovascular LLS, 45...

Name: Z-0866-2010 EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm: L: 50 mm straight Maquet Cardiovascular LLS, 45...
Creator: Maquet Cardiovascular, LLC
Published: 2010-01-20
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2010-01-20 / Terminated / root cause: labeling and UDI

FDA source

Maquet Cardiovascular, LLC began a recall of EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm: L: 50 mm straight Maquet Cardiovascular LLS, 45 Barbour Pond Drive, Wayne, NJ 07470 on 2010-01-20. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0866-2010
Status: Terminated
Initiated: 2010-01-20
Posted: 2010-02-26
Terminated: 2010-07-06
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
Product code: DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 18 units
Distribution: Product was distributed to hospitals in TX, TN, CT, AR, AZ as well as to Austria and France.
Product codes and lots: Product Code: M002004910580; Lot # 12633379, Exp: 4/2012

Product code DSY

K052964Class IIExxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted Vascular Grafts, Woven Double Velour WovenBoston Scientific Corp / cleared 2006-01-06

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)