Z-1456-2017 Class II Terminated
FDA device recall Z-1456-2017 was initiated by Maquet Cardiovascular, LLC on January 27, 2017 and is designated Class II. Reason for recall: Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the device exhibiting the failure mode of intermittent or no power. The recall status is terminated (terminated April 12, 2018). Affected quantity: 4283 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2017
- Initiation Date
- January 27, 2017
- Termination Date
- April 12, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4283 units
Product Description
VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with the 7-mm Endoscope and is intended for specific use with the VASOVIEW HEMOPRO Power Supply.
Reason for Recall
Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the device exhibiting the failure mode of intermittent or no power.
Distribution Pattern
US Nationwide Distribution
Code Information
25126012, 25126080, 25126250, 25126375, 25126542, 25126659, 25128301, 25128602, 25128820, 25128905, 25129016, 25129155, 25129199, 25129239, 25129286, 25129335, 25129416, 25129513