—#194013

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

FDA product code: DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K984294
Affected lot / code info: UDI: (01)00384401000280(11)201112(17)251031(21)1303435656GS(10)20L12; Lot number: 20L12 Serial number: 1303435656

Why it was recalled

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 (FDA determination)

Packaging process control

Action the firm took

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 INTERGARDwovengraft.act@getinge.com or by FAX to 1-877-485-5541

Recalling firm

Firm: Maquet Cardiovascular, LLC
Address: 45 Barbour Pond Dr, Wayne, New Jersey 07470-2094

Distribution

Distribution pattern: US Nationwide distribution in the state of SC.

Timeline

Recall initiated: 2022-04-29
Terminated: 2024-04-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.