Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.
Summary
The FDA issued a Class II for Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500. by Maquet Cardiovascular, LLC. Reason: Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter .
Details
Source
Device Recall
External ID
Z-0724-2024
Action Date
2024-01-24
Status
Ongoing
Category
device
Product Description
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.
Lot/Code Info: 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.
Quantity Affected: 38,094 units (US)
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.
Distribution
US: OUS: China, Brazil, Hong Kong.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-01
Company
Wayne, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Maquet Cardiovascular, LLC has 41 FDA actions in our database, including 37 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Maquet Cardiovascular, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Maquet Cardiovascular, LLC have FDA actions?
Maquet Cardiovascular, LLC has 41 FDA actions in our database, including 37 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0724-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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