CLASS II Device recall · Reported 10 May 2017 · FDA Enforcement Report
The Jetstream is a rotational atherectomy catheter system recalled
Boston Scientific is recalling The Jetstream is a rotational atherectomy catheter system designed for use in debulking, distributed in 23 states. The recall was initiated on 5 Apr 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1922-2017
- FDA event ID
- 76955
- Recalling firm
- Boston Scientific, Maple Grove, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Apr 2017
- FDA classified
- 2 May 2017
- Reported
- 10 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 5 Apr 2017 | Recall initiated by company | |
| 2 May 2017 | Classified by FDA | +27 days |
| 10 May 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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
AlabamaArizonaConnecticutFloridaHawaiiIowaIllinoisKentuckyLouisianaMaineMichiganMissouriNew JerseyNew YorkOhioOregonPennsylvaniaSouth CarolinaTennesseeTexas
Questions about this recall
Why was it 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.
Which lots are affected?
18775553, 18775552, 18822086
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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