Boston Scientific Corporation MCWClass II

Catheter, Peripheral, Atherectomy

Boston Scientific Corporation's record for this product code

MDR events1,312All time

Recalls1All time

510(k) clearances2All time

Recent MDR events

1,312 adverse event reports on file

Recalls

1 recall events for this product code

TerminatedApr 10, 2017
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.
View FDA record ↗

510(k) clearances

2 clearances for this product code