Z-1607-2010

EXXCEL Soft Thin Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. Sterile

Name: Z-1607-2010 EXXCEL Soft Thin Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. Sterile
Creator: Maquet Cardiovascular, LLC
Published: 2010-03-26
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2010-03-26 / Terminated / root cause: labeling and UDI

FDA source

Maquet Cardiovascular, LLC began a recall of EXXCEL Soft Thin Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. Sterile Intended use: The Standard Wall EXXCEL and EXXCEL Soft ePTFE Vascular Grafts are... on 2010-03-26. The reason FDA records is "This is an expansion of Recall # Z-866-2010, adding an additional two lots to the recall of EXXCEL soft Stand Wall EPTFE Vascular Grafts due to a labeling mix up". 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-1607-2010
Status: Terminated
Initiated: 2010-03-26
Posted: 2010-05-14
Terminated: 2012-04-23
Recalling firm: Maquet Cardiovascular LLC
Product: EXXCEL Soft Thin Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. Sterile Intended use: The Standard Wall EXXCEL and EXXCEL Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Wall Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries.
Product code: DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Reason for recall: This is an expansion of Recall # Z-866-2010, adding an additional two lots to the recall of EXXCEL soft Stand Wall EPTFE Vascular Grafts due to a labeling mix up.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm, MAQUET Cardiovascular, LLC, sent a "DEVICE REMOVAL IMMEDIATE ACTION REQUIRED" letter dated March 23, 2010, to all customers via Federal Express. The letter describes the product, problem and action to be taken by customers. The customers were instructed to examine their stock immediately to determine if they have any of the affected product from the lot, discontinue dispensing the lot and complete and return by fax (973-709-6511) the enclosed Field Action Response Form whether or not they have any affected products. Please contact your local MAQUET cardiovascular sales representative or Customer Service at 1-888-880-2874 for the exchange.
Quantity in commerce: 1 unit
Distribution: Worldwide distribution: USA including states of TX, NJ, SC, MO, ID, TN, FL, CA, PA and Canada and Germany.
Product codes and lots: UPN M002004948580; Lot 11407455, Exp 12/2010.

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)