CLASS II ONGOING Device recall · Reported 24 Jan 2024 · FDA Enforcement Report
Vasoview Hemopro Endoscopic Vessel Harvesting System recalled
Maquet Cardiovascular is recalling Vasoview Hemopro Endoscopic Vessel Harvesting System. The recall was initiated on 1 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0724-2024
- FDA event ID
- 93615
- Recalling firm
- Maquet Cardiovascular, Wayne, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Dec 2023
- FDA classified
- 12 Jan 2024
- Reported
- 24 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Surgical Instruments
Timeline
| 1 Dec 2023 | Recall initiated by company | |
| 12 Jan 2024 | Classified by FDA | +42 days |
| 24 Jan 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.
Where it was distributed
US: OUS: China, Brazil, Hong Kong.
Questions about this recall
Why was it 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.
Which lots are affected?
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.
Where was it sold?
US: OUS: China, Brazil, Hong Kong.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 93615This product is part of a recall event; the main page for the event is Vasoview Hemopro Endoscopic Vessel Harvesting System recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Vasoview Hemopro Endoscopic Vessel Harvesting System recalled | Maquet Cardiovascular | Particulate Matter | NJ |
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|---|---|---|---|---|---|
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