Vasoview Hemopro recallZ-0724-2024 · Maquet Cardiovascular, LLC · initiated Dec 1, 2023
Open, Classified
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
Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or peripheral bypass graft surgery.
FDA root cause category: Component design/selection
What the company is doing
An Urgent Medical Device Correction notice dated December 1, 2023 was sent via FedEx 2-Day delivery. Please examine your inventory immediately to determine if you have any of the product codes and lot numbers listed in the notice and remove these from use. Return any unused/unexpired affected product to Maquet/Getinge. Please forward this information to all current and potential VasoView HemoPro EVH System users within your hospital / facility. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. If you have any questions, please contact your Maquet/Getinge representative or call the Maquet/Getinge Customer Support at 888-880-2874, Monday through Friday, between the hours of 6 AM to 5 PM (Pacific Standard Time). Whether or not your facility has affected product listed in the notice, please complete and sign the MEDICAL DEVICE REMOVAL - RESPONSE FORM to acknowledge that you have received the notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to 1-800-878-9105.
Recall details
- Recall number
- Z-0724-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 1, 2023
- Posted by the FDA
- Jan 12, 2024
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- 38,094 units (US)
- Product code
- GEI
- FDA submissions
- K153194
- Distribution
- US: OUS: China, Brazil, Hong Kong.
Product description
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
UDI-DI: 00607567701250, Lots: 3000279266, 3000280189, 3000281082, 3000281083, 3000281381, 3000282927, 3000283156, 3000281741, 3000286706, 3000287254, 3000288363, 3000288576, 3000289020, 3000289548, 3000289927, 3000290482, 3000291429, 3000291157, 3000291645, 3000292098, 3000293522, 3000293788, 3000293823, 3000295050, 3000294365, 3000295346, 3000296172, 3000296021, 3000296498, 3000297028, 3000300016, 3000299854, 3000300155, 3000300260, 3000301042, 3000301666, 3000302760, 3000303282, 3000303854, 3000304912, 3000304645, 3000306277, 3000306437, 3000307090, 3000307871, 3000308725, 3000310691, 3000311127, 3000311525, 3000311892, 3000312494, 3000312722, 3000314373, 3000314821, 3000316023, 3000316027, 3000316024, 3000317576, 3000317501, 3000317575, 3000318901, 3000318302, 3000320140, 3000320141, 3000320773, 3000320773, 3000321483, 3000321723, 3000323214, 3000324409, 3000324397, 3000325013, 3000325249, 3000325689, 3000325776, 3000328206, 3000328561, 3000329723, 3000328562, 3000330445, 3000331131, 3000331388, 3000332428, 3000332510, 3000332993, 3000333524, 3000333829, 3000334315, 3000335670, 3000336708, 3000337272, 3000339701, 3000340534, 3000341675, 3000341133, 3000342250, 3000342251, 3000343266, 3000343264, 3000344887, & 3000351187.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Vasoview Hemopro VH-3500Maquet Cardiovascular LLC · Electrosurgical, Cutting & Coagulation & Accessories4 recalls618 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 93615).
- Z-0723-2024 · Open, ClassifiedVasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
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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