Recall Z-1922-2017— Boston Scientific Corporation

Name: FDA recall Z-1922-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-05

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2017-04-05, terminated 2019-05-10. It names one FDA 510(k) clearance: K133023. Product: 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.. Reason: 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..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-04-05
Terminated: 2019-05-10
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K133023 — JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6Medrad, Inc.·cleared 2014-08-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.