VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System Recalled for Sterilization Failure
Maquet Cardiovascular is recalling approximately 2,300 units of the VASOVIEW HEMOPRO 2 system because some batches were not sterilized to specification. This sterilization failure creates a risk of contamination and potential infection during surgical procedures.
What this means for you
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 of a surgical device used in invasive cardiac procedures. While no illnesses or injuries have been reported, sterilization failure on medical instruments poses a serious risk-of-harm, meeting the criteria for a High severity classification.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000. The FDA classified this recall as Class II. Approximately 2,300 units are affected worldwide, with distribution to the United States, Brazil, and China.
The reason for the recall is that some batches of the product were not sterilized to their minimum sterilization specification. This sterilization failure creates a potential risk of device contamination, which could lead to infection during endoscopic vessel harvesting procedures used in cardiac surgery.
The recalled devices are identified by the following lot numbers: 3000278401, 3000271148, 3000268643, 3000263026, 3000274504, and 3000263925. Healthcare facilities and professionals using this system should verify their lot numbers against this recall information and contact Maquet Cardiovascular for further instructions regarding affected units.
The recalled product
- Product
- VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- sterilization-failure
- infection-risk
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 (7)
- UDI-DI: 00607567700406
- Lot Numbers: 3000278401
- 3000271148
- 3000268643
- 3000263026
- 3000274504
- 3000263925
Distribution
Distributed nationwide across the United States.
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