Recall Z-0509-2024— Spectranetics Corporation
Class II · Ongoing
Class II FDA medical device recall by Spectranetics Corporation, initiated 2023-11-15. It names one FDA 510(k) clearance: K170059. 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..
- Recalling firm
- Spectranetics Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-15
- 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 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 for recall
Incorrect product labeling. Exterior product box label does not match internal pouch label.
Data sourced from openFDA. This site is unofficial and independent of the FDA.