AngioJet¿ Ultra 5000 A Console:Foot Switch Material recall
AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that controls the…
Why was AngioJet¿ Ultra 5000 A Console:Foot Switch Material 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial number ranges:U2000 - U4530 U5001 - U5233; U6001 - U6197; U6300 - U6374 ; U6376 - U6432; U8001 - U8276; U8500 - U8719; U8800 - U8829; U8831 - U8869.
- Product
- AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that controls the…
- Recalling firm
- Boston Scientific Corporation
- 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, 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
- Recall date
- March 15, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)