Spectranetics AngioSculpt PTCA Scoring Balloon Catheter — Class II medical device recall Z-0576-2020
Terminated recall by Spectranetics Corporation, reported 2019-12-04, distributed in IA, MI, NJ. The incorrect outer carton box was used for the product.
| Recall number | Z-0576-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spectranetics Corporation, Fremont, CA, United States |
| Recall initiated | 2018-12-07 |
| Classified | 2019-11-26 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2020-10-27 |
| Distributed | IA, MI, NJ |
| Quantity | 3 catheters |
| Lot numbers | G18090030 |
| Model numbers | 2027-2515 |
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 for recall
The incorrect outer carton box was used for the product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0576-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.