Endoscopic vessel harvesting system recalled for sterilization defect
900 units of Maquet Cardiovascular's VASOVIEW HEMOPRO endoscopic vessel harvesting system are being recalled because some batches were not sterilized to their minimum specification, creating a potential infection risk for surgical patients.
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: FDA Class II medical device recall for sterilization failure. No illnesses or injuries reported. Sterilization defects in surgical instruments pose direct infection risk to patients, qualifying this as High severity under the criterion for risk-of-harm products without reported injury.
Plain-English summary
The U.S. Food and Drug Administration is recalling 900 units of the VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500, manufactured by Maquet Cardiovascular, LLC. This surgical device is used to harvest blood vessels during cardiac and vascular procedures.
Some batches of the product were not sterilized to their minimum sterilization specification. Inadequate sterilization of surgical instruments creates a risk that the device may not be free from contamination when used in surgery, potentially exposing patients to infection.
The affected units have been distributed worldwide, including throughout the United States and in Brazil and China. The affected lot numbers are 3000280189 and 3000276183. Healthcare facilities that have received this product should contact Maquet Cardiovascular, LLC immediately for recall instructions and replacement product information.
The recalled product
- Product
- VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- sterilization-defect
- 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 (3)
- UDI-DI: 00607567701250
- Lot Numbers: 3000280189
- 3000276183
Distribution
Distributed nationwide across the United States.
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