Z-0724-2024Class II

Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500

Name: Z-0724-2024 Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500
Creator: Maquet Cardiovascular, LLC
Published: 2023-12-01
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2023-12-01 / Open, Classified / root cause: design

FDA source

Maquet Cardiovascular, LLC began a recall of Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500 on 2023-12-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0724-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-01
Posted: 2024-01-12
Recalling firm: Maquet Cardiovascular LLC
Product: Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: 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.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 38,094 units (US)
Distribution: US: OUS: China, Brazil, Hong Kong.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0724-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0723-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-12
Z-0724-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-12

Product code GEI

K153194Class IIVASOVIEW HemoPro Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC / cleared 2016-04-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)