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.

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for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.

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 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(01)00813132024710(17)260215(10)FAY24B09A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A 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 FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A 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 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

Distribution pattern: 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.