Z-1282-2022Class II

INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external...

Name: Z-1282-2022 INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external...
Creator: Maquet Cardiovascular, LLC
Published: 2022-04-29
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2022-04-29 / Terminated / root cause: packaging

FDA source

Maquet Cardiovascular, LLC began a recall of INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The... on 2022-04-29. FDA classified it as Class II and gives the reason as "Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an Intergard Woven Straight graft of D: 32 mm and L: 30 cm". 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-1282-2022
Classification: Class II
Status: Terminated
Initiated: 2022-04-29
Posted: 2022-06-23
Terminated: 2024-04-18
Recalling firm: Maquet Cardiovascular LLC
Product: INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and bifurcated configurations, as well as hemabridge, aortic arch, thoracic aortic graft, and cardioroot configurations designed for use on the thoracic aorta
Product code: DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Reason for recall: Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an Intergard Woven Straight graft of D: 32 mm and L: 30 cm
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Intervascular SAS / Getinge issued Urgent Medical Device Removal letter via mail on April 29, 2022. Letter stated reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have the INTERGARD Woven Straight graft, Ref Number IGW0032-30, Lot 20L12, SN 1303435656. Please make sure that the affected product is segregated in a secure storage place to prevent any use of the product. Should you have the unused affected product, you are eligible for credit upon receipt of the Response Form (see page 4). Please contact Getinge Customer Service at 1-888-943-8872, (press option 2) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone), to request shipping instructions to return any affected product. Pack the product to be returned with the appropriate return documents. Whether you have affected product or not, please complete and sign the attached URGENT MEDICAL DEVICE REMOVAL RESPONSE FORM (page 4) to acknowledge this recall and return the completed form to Getinge by e-mailing a scanned copy to [email protected] or by FAX to 1-877-485-5541
Quantity in commerce: 1 unit
Distribution: US Nationwide distribution in the state of SC.
Product codes and lots: UDI: (01)00384401000280(11)201112(17)251031(21)1303435656GS(10)20L12; Lot number: 20L12 Serial number: 1303435656

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1282-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1282-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-29	2022-06-23

Product code DSY

K984294Class IIModification of Intergard Woven Collagen Coated Vascular ProsthesesIntervascular, Inc. / cleared 1999-02-22

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)