Recall Z-2863-2017— Spectranetics Corporation
Class II · Terminated
Class II FDA medical device recall by Spectranetics Corporation, initiated 2017-06-06, terminated 2021-07-08. It names one FDA 510(k) clearance: K170059. 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..
- Recalling firm
- Spectranetics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-06
- Terminated
- 2021-07-08
- Firm location
- Colorado Springs, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.