Z-1401-2017 Class II Terminated
FDA device recall Z-1401-2017 was initiated by Boston Scientific Corporation on January 31, 2017 and is designated Class II. 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. The recall status is terminated (terminated April 22, 2019). Affected quantity: 3402 units; 2626 in US; 786 units OUS.
Recall Details
- Product Type
- Devices
- Report Date
- March 15, 2017
- Initiation Date
- January 31, 2017
- Termination Date
- April 22, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3402 units; 2626 in US; 786 units OUS
Product Description
Reason for Recall
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