CLASS II ONGOING Device recall · Reported 1 Oct 2025 · FDA Enforcement Report
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System recalled
Maquet Cardiovascular is recalling Vasoview Hemopro 3 Endoscopic Vessel Harvesting System, distributed nationwide in the US. The recall was initiated on 6 Aug 2025 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-2636-2025
- FDA event ID
- 97469
- Recalling firm
- Maquet Cardiovascular, Wayne, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Aug 2025
- FDA classified
- 25 Sep 2025
- Reported
- 1 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 6 Aug 2025 | Recall initiated by company | |
| 25 Sep 2025 | Classified by FDA | +50 days |
| 1 Oct 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting kit designed for use with a 7 mm endoscope to cut and cauterize vessel branches. The HP3 Harvesting Tool features two curved, insulated jaws with heating elements that operate through heat and pressure rather than radiofrequency energy.
Where it was distributed
US Nationwide distribution in the states of FL, IL, MD & TX.
Questions about this recall
Is Vasoview Hemopro 3 Endoscopic Vessel Harvesting System recalled?
Yes. Maquet Cardiovascular recalled Vasoview Hemopro 3 Endoscopic Vessel Harvesting System on 6 Aug 2025. The recall is Class II and its status is Ongoing. Recall number Z-2636-2025.
Why was it recalled?
Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws.
Which lots are affected?
Model No. C-VH-6000; UDI: 00607567701274; Lot/Serial No. 3000486429, 3000487231, 3000487726, 3000488639.
Where was it sold?
US Nationwide distribution in the states of FL, IL, MD & TX.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Maquet Cardiovascular
All 252| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System recalled | Maquet Cardiovascular | Sterility | Nationwide |
| Device | CLASS II | Heartstring III Proximal Seal System Intravascular recalled | Maquet Cardiovascular | Packaging Defects | Nationwide |
| Device | CLASS II | Heartstring III Proximal Seal System Intravascular recalled | Maquet Cardiovascular | Packaging Defects | Nationwide |
| Device | CLASS II | Heartstring III Proximal Seal System recalled by Maquet Cardiovascular | Maquet Cardiovascular | Packaging Defects | Nationwide |
| Device | CLASS II | The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System recalled | Maquet Cardiovascular | Device Malfunction | Nationwide |
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