Recall Z-1456-2017— Maquet Cardiovascular, LLC
Class II · Terminated
Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2017-01-27, terminated 2018-04-12. It names one FDA 510(k) clearance: K153194. Product: 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: Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the device exhibiting the failure mode of intermittent or no power..
- Recalling firm
- Maquet Cardiovascular, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-27
- Terminated
- 2018-04-12
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.