Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 m
Summary
The FDA issued a Class II for Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Des by Spectranetics Corporation. Reason: 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 retrac.
Details
Source
Device Recall
External ID
Z-0680-2025
Action Date
2024-12-25
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: 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 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(01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24H02A (01)00813132024710(17)260819(10)FAY24H02A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A 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 FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A 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 FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A 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 FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23A17A (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 (01)00813132024710(17)250814(10)FAY23H02A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY23H31A (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
Quantity Affected: 40,276 catheters
Reason for Recall
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.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-25
Company
Colorado Springs, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Spectranetics Corporation has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Spectranetics Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Spectranetics Corporation have FDA actions?
Spectranetics Corporation has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0680-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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