Hemashield recallZ-0403-2022 · Maquet Cardiovascular, LLC · initiated Dec 1, 2021
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
There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead of a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1260004700; 18 mm x 9 mm; REF Number M002020851890 or a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1259882880; 18 mm x 9 mm; Ref Number M002020851890.
FDA root cause category: Labeling Change Control
What the company is doing
And URGENT MEDICAL DEVICE REMOVAL notification letter dated 12/1/21 was sent to customers. Actions to be taken: " If you have already implanted one of the above-mentioned devices, 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 one of the Hemashield Gold Knitted Bifurcated Vascular Graft with a Serial Number matching those listed on page 1 of this letter. " Should you have un-used affected product, you are eligible for credit or a replacement at no cost to your facility upon receipt of Response Form (see page 4). " To get your free replacement Graft we need you to provide a ship to contact and your acknowledgment on 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 877-258-1332. " Please forward this information to all current and potential Hemashield Gold Knitted Microvel double velour vascular graft users within your hopsital / facility. " If you are a distrubutor who has shipped any affected product to customers, please forward this document to their attention for appropriate action. This voluntary recall only affects the product with the serial number and lot number listed on page 1; no other products
Recall details
- Recall number
- Z-0403-2022
- Status
- Terminated
- Initiated by the company
- Dec 1, 2021
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- 2
- Product code
- MAL
- FDA submissions
- K954848
- Distribution
- US Nationwide distribution in the states of IL and NC.
Product description
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Code information (models, lots, serial numbers)
Lot number: 20C04; Serial Numbers: 1260004700 and 1259882880; UDI Code: (01)00384401017752(11)200304(17)250228(21)1260004700GS(10)20C04 (01)00384401017752(11)200304(17)250228(21)1259882880GS(10)20C04
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Hemashield M002020851890Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite1 recall2 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 M002020952070Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite1 recall0 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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