—#153077

Product

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 product code: MCX — Catheter, Coronary, Atherectomy
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P980037
Affected lot / code info: Serial number ranges:U2000 - U4530 U5001 - U5233; U6001 - U6197; U6300 - U6374 ; U6376 - U6432; U8001 - U8276; U8500 - U8719; U8800 - U8829; U8831 - U8869.

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 47215 Lakeview Blvd, Fremont, California 94538-6530

Distribution

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

Timeline

Recall initiated: 2017-01-31
Terminated: 2019-04-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153077. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.