Spectranetics Turbo-Elite Laser Atherectomy Catheters Recalled for Marker Band Risk
Spectranetics is recalling Turbo-Elite Laser Atherectomy Catheters because a marker band may become loose or disengaged when the device is used off-label.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Spectranetics Corporation is recalling Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters. The device is indicated for the treatment, including atherectomy, of infrainguinal stenosis and occlusions. The recall involves Model Numbers 414-159 (1.4mm), 417-156 (1.7mm), and 420-159 (2.0mm).
The recall is due to a potential for the fluoroscopically visible marker band at the tip of the catheter to become loose or disengaged from the catheter when the device is used in an off-label manner. The agency has classified this as a Class II recall.
The products were distributed worldwide, including in the United States (specific states listed in source) and foreign countries such as Bahrain, Brazil, Canada, Italy, Japan, and the Netherlands. Healthcare providers and facilities should stop using the affected devices and contact Spectranetics Corporation for further instructions.
The recalled product
- 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
- Manufacturer
- Spectranetics Corporation
- Category
- Medical Device — Catheter
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 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.
Distribution
Related recalls
Same manufacturer · Spectranetics Corporation
See all →- CriticalVascular Tack Endovascular System recalled for deployment and migration risks
FDA (Devices) · 2025-02-26
- HighLaser Atherectomy Catheter Recalled for Marker Band Detachment Risk
FDA (Devices) · 2024-12-25
- ModerateSpectranetics Turbo-Elite Atherectomy Catheters recalled due to labeling mismatch
FDA (Devices) · 2023-12-20
- HighPhilips Laser System may enter non-recoverable error state
FDA (Devices) · 2022-11-23
- ModeratePhilips LAS-100 Laser System may not operate due to detected hardware failure
FDA (Devices) · 2022-07-20
Same hazard · device failure
See all →- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12