Hemashield recallZ-0729-2022 · Maquet Cardiovascular, LLC · initiated Jan 14, 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
Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Straight Vascular Graft, D: 7 mm L: 60 cm). Mislabeled product could cause a disruption of the vascular anastomosis in the long term, creating a pseudo-aneurysm
FDA root cause category: Packaging process control
What the company is doing
Getinge issued Urgent Medical Device Letter onJanuary 14, 2022, (via FedEx overnight) with adult signature required. Letter states reason for recall, health risk and action to take: Actions to be taken: " If you have already implanted the above-mentioned device, kindly notify us as soon as possible by contacting your Getinge representative or Customer Service (at 1-888-943-8872, options 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. You will be contacted shortly by our Medical Affairs Officer in order to discuss the appropriate follow up. " Please examine your inventory immediately to determine if you have the HEMASHIELD GOLD Product Knitted Microvel Double Velour Straight Vascular Graft (D: 7 mm; L: 60 cm) SN 1318567653, Ref Number M002020952070. " Should you have the un-used affected product, you are eligible for credit upon receipt of 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 Hemashieldgold- [email protected] or by FAX to 8772811346. " Please forward this information to all current and potential Hemashield Gold Knitted Microvel Double Velour Vascular Graft users within your hospital / facility. " If you are a distributor who has shipped any affected product to customers, please forward this document to their attention for appropriate action. If you have any questions, please contact your Getinge representative or, for technical questions, please contact Customer Service (at 1-888-943-8872, options 2), Monday th
Recall details
- Recall number
- Z-0729-2022
- Status
- Terminated
- Initiated by the company
- Jan 14, 2022
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- 1 unit
- Product code
- MAL
- FDA submissions
- K954848
- Distribution
- US Nationwide distribution in the state of MO.
Product description
HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Code/REF Number: M002020952070
Code information (models, lots, serial numbers)
Lot Number: 21B10 S/N: 1318567653 UDI: (01)00384401017608(11)210210(17)260131(21)1318567653GS(10)21B10
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Hemashield M002020952070Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite1 recall0 reports
Product lines
Other devices under the same FDA submission
14 devices cleared under K954848 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Hemashield M002020851890Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite1 recall2 reports
- Hemashield M002020954080Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite4 reports
- Hemashield M002020851680Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite4 reports
- Hemashield M002020852010Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite4 reports
- Hemashield M002020852210Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite4 reports
- Hemashield M002020951080Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite2 reports
- Hemashield M002020952060Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite2 reports
- Hemashield M002020952100Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite2 reports
- Hemashield M002020851260Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite2 reports
- Hemashield M002020851480Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite2 reports
- Hemashield M002020952160Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite1 report
- Hemashield M002020955070Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite1 report
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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