Reported Mar 15, 2017 · Terminated
AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 47215 Lakeview Blvd · Fremont, CA · 94538-6530
Is this the product you have?
- AngioJet¿
- Ultra 5000 A ConsoleFoot Switch Material
- number (U PN) 105650 CardiovascularThe 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
- Lot codes and dates
- Serial number ranges
U2000 - U4530 U5001 - U5233U6001 - U6197U6300 - U6374U6376 - U6432U8001 - U8276U8500 - U8719U8800 - U8829U8831 - U8869
- Serial number ranges
- Amount recalled
- 3402 units; 2626 in US; 786 units OUS
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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