Bridge Occlusion Balloon — Class II medical device recall Z-0663-2017
Terminated recall by Spectranetics Corporation, reported 2016-12-07, distributed nationwide. Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Co
| Recall number | Z-0663-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spectranetics Corporation, Colorado Springs, CO, United States |
| Recall initiated | 2016-10-31 |
| Classified | 2016-12-01 |
| Reported by FDA | 2016-12-07 |
| Terminated | 2017-04-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BH, BR, CA, CH, CL, CO, CY, DE, DK, DO, ES, FR, GB, HU, IL, IT, JP, KW, NL, NO, PL, SE, TH, TW |
| Quantity | 873 units |
| Reason classes | sterility, device malfunction |
| Model numbers | 590-001 |
Product
Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended.
Reason for recall
Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
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-0663-2017. 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.