The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in
FDA device recall Z-1922-2017 · posted 2017-04-10 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MCW
- Quantity affected
- 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
- Date initiated
- 2017-04-05
- Date posted
- 2017-04-10
- Date terminated
- 2019-05-10
- Location
- Maple Grove, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6 (K133023) | Medrad, Inc. | 2014-08-27 |