Recall Z-0680-2025 ยท MCW Catheter, Peripheral, Atherectomy
Spectranetics Corporation
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 / 98
| Date | Dec 16, 2024 (initiated Nov 25, 2024) |
| Status | Open, Classified |
| 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for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted. |
| Root cause | Device Design |
| Action | On 11/25/2024, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter via USPS certified mail to customer informing them that Philips has become aware of a potential safety issue with a limited number of Turbo-Elite Laser Atherectomy Catheters where the marker band has the potential to become detached from the device. Detached marker band are visible under fluoroscopy and should remain on the guidewire. Since a detached marker band requires additional intervention to retrieve, temporary or medically reversible adverse health consequences are possible. The potential clinical harms of a deta |
| Quantity | 40,276 catheters |
| 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, Ger |
| FDA record | Open on fda.gov |