Quick Facts at a Glance
- Recall Date
- August 6, 2025
- Hazard Level
- HIGH
- Brand
- Maquet Cardiovascular
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Maquet Cardiovascular
- Product type
- Endoscopic Vessel Harvesting System
- Model numbers
- C-VH-6000, VH-6000, VH-6001, VH-6010
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 6, 2025
Reported by FDA DEVICE
October 1, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
On August 5, 2025, Getinge voluntarily initiated a Medical Device Removal for the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System in response to reports of out-of-box failures discovered during the limited launch phase. There were sixteen complaints on the same date pertaining to specific failure modes, including 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. These sixteen complaints corresponded to sixteen total device malfunctions affecting devices that had not progressed to the pre-test step or clinical use. Notably, no serious injuries were reported in association with these device failures, as the non-conforming devices were identified during device inspection prior to patient exposure.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Maquet Cardiovascular, LLC or your healthcare provider for instructions. Notification method: Telephone
About This Product
Vasoview Hemopro 3 EVH System is a vessel harvesting kit used with a 7 mm endoscope to cut and cauterize vessel branches during EVH procedures.
Why This Is Dangerous
Out-of-box failures include deformities and uncompleted jaw closure and heater wire misalignment, detected during inspection before patient exposure.
Industry Context
This recall is not part of a broader pattern.
Real-World Impact
No injuries reported; devices flagged before clinical use. Facilities must halt use and return or service devices.
Practical Guidance
How to identify if yours is affected
- Confirm distribution states FL, IL, MD, TX
Where to find product info
Model No. C-VH-6000; UDI 00607567701274; Lot/Serial Nos listed above
What timeline to expect
Refund or replacement timelines not specified; follow manufacturer guidance
If the manufacturer is unresponsive
- Escalate to FDA recall contact
- Request written confirmation
- Document all communications
How to prevent similar issues
- Routinely inspect devices upon receipt
- Follow sterile field protocols
- Ensure supplier documentation and traceability
- Ask distributors for pre-shipment inspection certificates
Documentation advice
Maintain photos of defects, serial numbers, communications with hospital procurement and manufacturer
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Product Details
Model No. C-VH-6000. UDI: 00607567701274. Lot/Serial Nos: 3000486429, 3000487231, 3000487726, 3000488639. Distribution: US nationwide in FL, IL, MD, TX. Quantity: 98 units. Sold/Used: Medical facilities. Manufacturer: Maquet Cardiovascular.
Reported Incidents
Sixteen complaints reported on the same date, August 5, 2025. No serious injuries associated with these device failures. Issues identified during inspection prior to patient exposure.
Key Facts
- 98 total units recalled
- 16 complaints on August 5, 2025
- Model No. C-VH-6000
- Distributed to FL, IL, MD, TX
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Safety Guide
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