Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall AngioJet Ultra 5000 A Console:

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall AngioJet Ultra 5000 A Console:see related information
Date Initiated by FirmJanuary 31, 2017
Create DateMarch 03, 2017
Recall Status1 Terminated 3 on April 22, 2019
Recall NumberZ-1401-2017
Recall Event ID 76400
PMA NumberP980037 
Product Classification Catheter, coronary, atherectomy - Product Code MCX
ProductAngioJet 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.
Code Information Serial number ranges:U2000 - U4530  U5001 - U5233;  U6001 - U6197;  U6300 - U6374 ;  U6376 - U6432;  U8001 - U8276;  U8500 - U8719;  U8800 - U8829;  U8831 - U8869. 
FEI Number 2939204
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
47215 Lakeview Blvd
Fremont CA 94538-6530
For Additional Information ContactClara Johnson
763-955-8131
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionField 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 in Commerce3402 units; 2626 in US; 786 units OUS
DistributionUS 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = MCX
-
-