Laser Atherectomy Catheter Recalled for Marker Band Detachment Risk
Spectranetics is recalling the Turbo Elite Laser Atherectomy Catheter because the marker band can detach from the catheter tip and remain in the patient. This defect was identified through customer complaints.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall involving a mechanical failure where the marker band detaches from the catheter tip and remains in the patient. No illnesses or injuries have been reported, but the hazard represents a significant risk: a retained foreign object in a blood vessel.
Plain-English summary
Spectranetics Corporation has recalled multiple models of its Turbo Elite Laser Atherectomy Catheter due to complaints that the marker band can detach from the catheter's distal tip and remain in the patient during the procedure.
The catheters are used in the treatment of infrainguinal stenoses and occlusions—narrowing and blockages in blood vessels below the groin. The marker band serves as a visualization component during the procedure. When detachment occurs during catheter retraction, the marker band may remain as a retained object inside the patient's vasculature.
Approximately 40,276 catheters have been distributed in the United States and internationally to countries including Australia, Belgium, Brazil, China, Japan, and the United Kingdom. The recall encompasses nine different model numbers with catheter diameters ranging from 1.4 mm to 2.5 mm.
Patients who received these devices should consult their healthcare provider to determine if they may be affected. Healthcare facilities should quarantine affected inventory and review patient records for potentially affected implants.
The recalled product
- 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…
- Manufacturer
- Spectranetics Corporation
- Affected units
- 40,276
Distribution
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