FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular, LLC: 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
- Recall number
- Z-1282-2022
- 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
- Status
- Terminated
- Initiated
- 2022-04-29
- Posted
- not on file
- Terminated
- 2024-04-18
- Reason
- 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
- 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 INTERGARDwovengraft.act@getinge.com or by FAX to 1-877-485-5541
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of SC.
- Lot, serial or model codes
- UDI: (01)00384401000280(11)201112(17)251031(21)1303435656GS(10)20L12; Lot number: 20L12 Serial number: 1303435656
- 510(k) numbers
- ["K984294"]
- PMA numbers
- not on file
- Product code
- DSY
- Firm FEI
- 2242352
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28