FDA Device recall Z-2863-2017
Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, incl…
- FDA Device
- Class II
- terminated
- Published 2017-08-09
On 2017-08-09 the FDA classified a Class II recall of Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, incl… by Spectranetics, citing potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Catheters to become loose or disengaged rom the catheter when the device….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2863-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-06 |
| Published | 2017-08-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Spectranetics |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV |
Product
Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions
Reason
Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Catheters to become loose or disengaged rom the catheter when the device is in use in an off-label manner.
Identifiers
| code_info | Model Number 414-159 Catheter Diameter 1.4mm, Model Number 417-156 Catheter Diameter 1.7mm, and Model Number 420-159 Catheter Diameter 2.0mm. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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 - 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 · 2023-12-20 · 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
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2863-2017%22
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