Intergard recallZ-1282-2022 · Maquet Cardiovascular, LLC · initiated Apr 29, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Cardiovascular, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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
FDA root cause category: Packaging process control
What the company is doing
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
Recall details
- Recall number
- Z-1282-2022
- Status
- Terminated
- Initiated by the company
- Apr 29, 2022
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- 1 unit
- Product code
- DSY
- FDA submissions
- K984294
- Distribution
- US Nationwide distribution in the state of SC.
Product description
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
Code information (models, lots, serial numbers)
UDI: (01)00384401000280(11)201112(17)251031(21)1303435656GS(10)20L12; Lot number: 20L12 Serial number: 1303435656
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Intergard IGW0032-30Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 reports
Product lines
Other devices under the same FDA submission
7 devices cleared under K984294 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Intergard IGW0028-30Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter9 reports
- Intergard IGW0028-15Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter2 deaths7 reports
- Intergard IGW0030-30Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter5 reports
- Intergard IGW0026-15Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter4 reports
- Intergard IGW0030-15Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter4 reports
- Intergard IGW0026-30Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter3 reports
- Intergard IGW0032-15Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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