FDA Device recall Z-0576-2020
Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The…
- FDA Device
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The… by Spectranetics, citing the incorrect outer carton box was used for the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0576-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-07 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Spectranetics |
| Distribution | IA, MI, NJ |
Product
Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.
Reason
The incorrect outer carton box was used for the product.
Identifiers
| code_info | AngioSculpt PTCA lot #G18090030. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0576-2020%22
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