Terminated

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.

FDA Recall Z-1401-2017 · Posted None

Recalling FirmBoston Scientific Corporation

Recall StatusTerminated

Product CodeMCX

Date Initiated2017-01-31

Date Terminated2019-04-22

Product Quantity3402 units; 2626 in US; 786 units OUS

Reason for Recall

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.

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 [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

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, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Puerto Rico, Russian Fed. ,Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, United Arab Emir., Venezuela, Virgin Islands, W.Bank/Gaza Strip

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.