Endoscopic Vessel Harvesting System Recalled Due to Polyimide Particulate Matter Risk
Maquet Cardiovascular is recalling 38,094 units of the Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500, due to polyimide particulate matter contamination that may be introduced into the arterial conduit during coronary artery bypass or peripheral bypass surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalization. The hazard is theoretical—polyimide particulate matter may result in complications during bypass surgery. Per the severity rubric, a risk-of-harm product where injury has not yet been reported scores 3 (High).
Plain-English summary
Maquet Cardiovascular, LLC is recalling 38,094 units of the Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500, due to contamination concerns. The FDA has classified this as a Class II recall.
The device may contain polyimide particulate matter that could be introduced into the arterial conduit during coronary artery bypass graft (CABG) or peripheral bypass graft surgery. This contamination could potentially affect the graft during or after the surgical procedure.
Affected lot numbers are identified in the official FDA notice. The recall impacts units distributed in the United States, China, Brazil, and Hong Kong.
Healthcare facilities using this device should verify their inventory against the affected lot numbers and contact Maquet Cardiovascular or their FDA representative for further guidance. Patients with concerns about their care should consult with their healthcare providers.
The recalled product
- Product
- Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.
- Manufacturer
- Maquet Cardiovascular, LLC
- Affected units
- 38,094
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 00607567701250
- Lots: 3000279266
- 3000280189
- 3000281082
- 3000281083
- 3000281381
- 3000282927
- 3000283156
- 3000281741
- 3000286706
- 3000287254
- 3000288363
- 3000288576
- 3000289020
- 3000289548
- 3000289927
- 3000290482
- 3000291429
- 3000291157
- 3000291645
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Maquet Cardiovascular, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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