Recall Z-0680-2025— Spectranetics Corporation

Name: FDA recall Z-0680-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-25

Class II · Ongoing

Class II FDA medical device recall by Spectranetics Corporation, initiated 2024-11-25. It names 2 FDA 510(k) clearances: K170059, K123632. 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.. 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for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted..

Recalling firm: Spectranetics Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-11-25
Firm location: Colorado Springs, CO, United States

510(k) clearances named in this recall

2 on FDA's record

K170059 — Spectranetics Turbo-Elite Laser Atherectomy CathetersSpectranetics, Inc.·cleared 2017-04-07
K123632 — 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035Spectranetics Corp.·cleared 2013-01-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

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for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.

Data sourced from openFDA. This site is unofficial and independent of the FDA.