Reported May 10, 2017 · Terminated
The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease…
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 · 2 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature. The System includes multiple distal ports located at the catheter tip, which are designed to provide independent infusion and aspiration functions for the active removal of fluid, excised tissue and thrombus from the peripheral treatment site.
- Lot codes and dates
187755531877555218822086
- Amount recalled
- 137
Where it was sold
Why it was recalled
Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1mm Atherectomy Catheters due to these units being mislabeled. Some 1.85mm JETSTREAM SC catheters may have been labeled as 2.1mm catheters, and some 2.1mm JETSTREAM XC catheters may have been labeled as 1.85mm catheters.
This product could cause temporary or reversible health problems — stop using it.
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