Recall Z-0509-2024 ยท MCW Catheter, Peripheral, Atherectomy
Spectranetics Corporation
Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.4 RX REF 414-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.7 OTW REF 417-152 The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal st
| Date | Dec 8, 2023 (initiated Nov 15, 2023) |
| Status | Open, Classified |
| Reason | Incorrect product labeling. Exterior product box label does not match internal pouch label. |
| Root cause | Packaging process control |
| Action | On 11/15/2023, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via US Postal Service Certified Mail to customers informing them that as a result of 3 complaints received the firm became aware that exterior box labels were incorrectly labeled and did not match the interior product pouch label. Customers are instructed to: -Immediately check their product inventory and quarantine any potentially affected devices from the affected lots. -Do not open or use any products that have been identified with their inventory -Complete and return the Response Form within 30 days so that Philips can |
| Quantity | 1,239 catheters |
| Distribution | U.S Nationwide - Worldwide Distribution: US Distribution: AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, and WA Foreign Distribution: Germany, Italy, Poland and Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170059 | Spectranetics Turbo-Elite Laser Atherectomy Catheters Spectranetics, Inc., Apr 7, 2017 |