FDA Medical devices recall · December 25, 2024

Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code /… recall

Read the official FDA notice ↗

Product

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for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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)FAY

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.

States: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Washington Wisconsin West Virginia

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0680-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.