—#154677

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.

FDA product code: MCW — Catheter, Peripheral, Atherectomy
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K133023
Affected lot / code info: 18775553, 18775552, 18822086

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.

Root cause (FDA determination)

Process control

Action the firm took

Consignees were sent a Boston Scientific "Urgent Medical Device Removal" letter dated April 5, 2017. The letter was addressed to Materials Manager / Field Action Contact. The letter described the issue and the prduct involved in the recall. Advised consignees to segregate and return the affected product to Boston Scintific. This recall is to be carried to the customer level. Requested consginees to complete and return the Account Reply Verification Tracking Form. Contact your local Sales Representative can answer any questions that you may have regarding this Removal.

Recalling firm

Firm: Boston Scientific Corporation
Address: 2 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: US: AL, AZ, CT, FL, HI, IL IN, IA, KY, LA, ME, MI, MO, NJ,NY, OH, OR, PA, SC, TN, TX, VA, WA, WI. OUS; GERMANY, GREAT BRITAIN, POLAND, NETHERLANDS

Timeline

Recall initiated: 2017-04-05
Posted by FDA: 2017-04-10
Terminated: 2019-05-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154677. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.