Class II FDA device recall · Z-0680-2025
Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW 423-001 / 989930000591 / 2.3 mm OTW 425-011 / 989930000601 / 2.5 mm OTW 423-135-01 / 989930004171 / 2.3 mm OTW 423-135-02 / 989930004181 / 2.3 mm OTW 425-135-01 / 989930004201 / 2.5 mm OTW 425-135-02 / 989930004211 / 2.5 mm OTW The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.
Why it was recalled
Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
Model Number / 12NC / Product Description 414-151 / 989930000531 / 1.4 mm OTW Lot Numbers / UDI codes: FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY24H02A (01)00813132024710(17)260819(10)FAY24H02A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY24B16A 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(01)00813132024710(17)251211(10)FAY23M06A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY24H02A (01)00813132024710(17)260819(10)FAY24H02A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A04A 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(01)00813132024710(17)250127(10)FAY23A17A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H02A 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(01)00813132024710(17)250912(10)FAY23H31A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24H02A (01)00813132024710(17)260819(10)FAY24H02A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H0
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, ILIN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD TN, TX, UT, VA, WA, WI, and WV. O.U.S.: Australia, Belgium, Brazil, China, Croatia, Cyprus, Czech Republic, Denmark, France, Germany, Italy, Japan, Kuwait, Netherlands, Poland, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
Recall record
- Recalling firm
- Spectranetics Corporation
- Product type
- Devices
- Recall number
- Z-0680-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Colorado Springs, CO
- Recall initiated
- 2024-11-25
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-0680-2025 · Source: openFDA enforcement.