Z-1922-2017Class II

The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular...

Name: Z-1922-2017 The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular...
Creator: Boston Scientific Corporation
Published: 2017-04-05
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2017-04-05 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature. The System... on 2017-04-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1922-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-05
Posted: 2017-04-10
Terminated: 2019-05-10
Recalling firm: Boston Scientific Corporation
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.
Product code: MCW Catheter, Peripheral, Atherectomy
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 137
Distribution: 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
Product codes and lots: 18775553, 18775552, 18822086

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1922-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1922-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-02

Product code MCW

K133023Class IIJetstream Xc 2.4/3.4; Jetstream Xc 2.1/3.0; Jetstream Sc 1.85; Jetstream Sc 1.6Medrad, Inc. / cleared 2014-08-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)