FDA Device recall Z-0509-2024
Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 42…
- FDA Device
- Class II
- ongoing
- Published 2023-12-20
On 2023-12-20 the FDA classified a Class II recall of Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 42… by Spectranetics, citing incorrect product labeling. Exterior product box label does not match internal pouch label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0509-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-15 |
| Published | 2023-12-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Spectranetics |
| Distribution | US |
Product
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 stenoses and occlusions in humans.
Reason
Incorrect product labeling. Exterior product box label does not match internal pouch label.
Identifiers
| code_info | Model Number: 420-159 UDI code: 01)00813132024734(17)250614(10)FAZ23F06A Lot Number: FBH23F02A Model Number: 420-006 U…Model Number: 420-159 UDI code: 01)00813132024734(17)250614(10)FAZ23F06A Lot Number: FBH23F02A Model Number: 420-006 UDI code: (01)00813132024758(17)250622(10)FBA23F09A Lot Number: FBA23F09A Model Number: 414-159 UDI code: (01)00813132024727(17)250621(10)FBF23F05B Lot Number: FBF23F05B Model Number: 417-152 UDI code: (01)00813132024765(17)250623(10)FBH23F02A Lot Number: FAZ23F06A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Spectranetics
- Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm,…
FDA Device · Class I · 2025-02-26 · Spectranetics - Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 98993…
FDA Device · Class II · 2024-12-25 · Spectranetics - Philips Laser System, REF: LAS-100
FDA Device · Class II · 2022-11-23 · Spectranetics - Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
FDA Device · Class II · 2022-07-20 · Spectranetics - Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Out…
FDA Device · Class II · 2020-06-03 · Spectranetics
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0509-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.