Recall Z-1401-2017 ยท MCX Catheter, Coronary, Atherectomy
Boston Scientific Corporation
AngioJet Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that controls the Thrombectomy Set. It drives the pump, regulates fluid inflow and outflow, provides the operator with Ultra System set-up prompts, total infused saline volume, and Ultra System malfunction warnings.
| Date | Jan 31, 2017 |
| Status | Terminated |
| Reason | Boston Scientific has received field reports regarding the AngioJet Ultra 5000 A Console foot switch sticking during use resulting in an undesired continued operation of the device. |
| Root cause | Under Investigation by firm |
| Action | Field notification letters were sent on January 31, 2017 by certified mail to affected customers. Letters request that Users follow the operator's manual for service and maintenance and if they notice that the foot switch is sticking to discontinue use and contact BSC Technical support at 1 800-949-6708 or CETechSupportUSA@bsci.com. |
| Quantity | 3402 units; 2626 in US; 786 units OUS |
| Distribution | US and Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Cyprus, Denmark, Dominican Rep., Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, Indonesia, Iraq, Ireland, Israel, Italy, Jordan, Lebanon, Lithua |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.