Z-2066-2010

Hemashield Gold Woven and Knitted Double Vascular Grafts

Name: Z-2066-2010 Hemashield Gold Woven and Knitted Double Vascular Grafts
Creator: Maquet Cardiovascular, LLC
Published: 2010-05-24
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2010-05-24 / Terminated / root cause: packaging

FDA source

Maquet Cardiovascular, LLC began a recall of Hemashield Gold Woven and Knitted Double Vascular Grafts on 2010-05-24. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2066-2010
Status: Terminated
Initiated: 2010-05-24
Posted: 2010-07-22
Terminated: 2011-07-14
Recalling firm: Maquet Cardiovascular LLC
Product: Hemashield Gold Woven and Knitted Double Vascular Grafts.
Product code: MAL Graft, Vascular, Synthetic/Biologic Composite
Reason for recall: 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 tag: packaging
FDA 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 in commerce: xx
Distribution: Nationwide Distribution.
Product codes and lots: xx

Product code MAL

K954848Class IIHemashield Microvel Velour Knitted Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. / cleared 1996-02-01

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)