AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R…
Medical device recall Z-0717-2020. Published in FDA’s Enforcement Report on Dec 25, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 25, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 169 units ((OUS: 44 US: 125) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator’s Manual.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-004R 105650-007R 105650-009R 105650-024H 105650-024Z 105650-025 105650-025H 105650-025R 105650-026R Product Usage - The AngioJet allows for percutaneous removal of thrombus located in peripheral arteries and veins, saphenous vein bypass grafts, native coronary arteries, and native or synthetic AV access conduits. Thrombectomy is accomplished using high-pressure saline jets contained in the catheter shaft. The saline jets create a low-pressure effect to draw thrombus into the catheter, fragment the thrombus, and remove the thrombus from the treatment site. The system consists of a single use Thrombectomy Set (several models available) and a free standing mobile Console.
169 units ((OUS: 44 US: 125), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UPN GTN SERIAL NUMBER 105650-001D 08714729892182¿ U2541 105650-001D 08714729892182¿ U2893 105650-001D 08714729892182¿ U3139 105650-001D 08714729892182¿ U4146 105650-001D 08714729892182¿ U5058 105650-001D 08714729892182¿ U5136 105650-001H…
Every code shown here, 1,994 characters
UPN GTN SERIAL NUMBER 105650-001D 08714729892182¿ U2541 105650-001D 08714729892182¿ U2893 105650-001D 08714729892182¿ U3139 105650-001D 08714729892182¿ U4146 105650-001D 08714729892182¿ U5058 105650-001D 08714729892182¿ U5136 105650-001H 08714729890591¿ U2259 105650-001H 08714729890591¿ U2262 105650-001H 08714729890591¿ U2379 105650-001H 08714729890591¿ U2552 105650-001H 08714729890591¿ U2613 105650-001H 08714729890591¿ U2851 105650-001H 08714729890591¿ U2976 105650-001H 08714729890591¿ U3460 105650-001H 08714729890591¿ U3535 105650-001H 08714729890591¿ U3611 105650-001H 08714729890591¿ U3731 105650-001H 08714729890591¿ U3819 105650-001H 08714729890591¿ U3939 105650-001H 08714729890591¿ U6400 105650-001R 08714729890607¿ U2003 105650-001R 08714729890607¿ U2004 105650-001R 08714729890607¿ U2007 105650-001R 08714729890607¿ U2021 105650-001R 08714729890607¿ U2023 105650-001R 08714729890607¿ U2025 105650-001R 08714729890607¿ U2042 105650-001R 08714729890607¿ U2052 105650-001R 08714729890607¿ U2054 105650-001R 08714729890607¿ U2056 105650-001R 08714729890607¿ U2066 105650-001R 08714729890607¿ U2080 105650-001R 08714729890607¿ U2092 105650-001R 08714729890607¿ U2094 105650-001R 08714729890607¿ U2117 105650-001R 08714729890607¿ U2133 105650-001R 08714729890607¿ U2149 105650-001R 08714729890607¿ U2185 105650-001R 08714729890607¿ U2192 105650-001R 08714729890607¿ U2193 105650-001R 08714729890607¿ U2199 105650-001R 08714729890607¿ U2206 105650-001R 08714729890607¿ U2208 105650-001R 08714729890607¿ U2219 105650-001R 08714729890607¿ U2260 105650-001R 08714729890607¿ U2282 105650-001R 08714729890607¿ U2285 105650-001R 08714729890607¿ U2312 105650-001R 08714729890607¿ U2313 105650-001R 08714729890607¿ U2336 105650-001R 08714729890607¿ U2337 105650-001R 08714729890607¿ U2340 105650-001R 08714729890607¿ U2370 105650-001R 08714729890607¿ U2396 105650-001R 08714729890607¿ U2419 105650-001R 08714729890607¿ U2420 105650-001R 08714729890607¿ U2452 105650-001R 08714729890607¿ U2458…
FDA’s list runs to 9,666 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide distribution and country of Canada.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 8, 2019.
- FDA classified it on Dec 19, 2019.
- FDA’s Enforcement Report published it on Dec 25, 2019.
- FDA terminated it on Mar 24, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Boston Scientific Corporation, of Marlborough, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 9,666 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.