FDAFDA · Food and drugs·Recall number Z-0680-2025
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.
Published December 25, 2024 · Recall initiated: November 25, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Spectranetics Corporation
- Distributor
- 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.
- Lot
- 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)FAY23M0
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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