Severity
Moderate
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.
Reported: May 10, 2017 Initiated: April 5, 2017 #Z-1922-2017 137 units
Boston Scientific Corporation issued this FDA Devices recall on May 10, 2017. Classified as Moderate severity (Class II). Approximately 137 units are affected. The recall was issued because: Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1m…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-1922-2017) was formally reported on May 10, 2017, with the manufacturer initiating the action on April 5, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Boston Scientific Corporation is listed as the recalling firm, operating out of Maple Grove, MN. Federal records indicate 137 units are affected.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: 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. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 9 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
137
Related Recalls
6
6 from same agency
Recall Progress (industry avg ~60%) 60.0%
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units 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
- Location
- Maple Grove, MN
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1922-2017 |
| Date reported | May 10, 2017 |
| Date initiated | April 5, 2017 |
| Recalling firm | Boston Scientific Corporation |
| Units 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 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Boston Scientific Corporation. Units affected: 137.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on May 10, 2017. Severity: Moderate. Recall number: Z-1922-2017.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1922-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).