Bridge Occlusion Balloon — Class II medical device recall Z-2143-2020
Terminated recall by Spectranetics Corporation, reported 2020-06-03, distributed nationwide. There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long duratio
| Recall number | Z-2143-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spectranetics Corporation, Colorado Springs, CO, United States |
| Recall initiated | 2020-03-31 |
| Classified | 2020-05-28 |
| Reported by FDA | 2020-06-03 |
| Terminated | 2022-10-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IS, IT, JO, JP, LT, LU, LV, MT, NL, NO, PL, PT, RO, SE, SI, SK, ZA |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00813132024666 |
| Model numbers | 590-001 |
Product
Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Marking, Sterile EO, UDI: 00813132024666
Reason for recall
There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. All users, such as those performing lead extraction cases may not be aware of this risk. It was determined that current labeling is insufficient to ensure all potential users minimize the time the balloon remains in vasculature. If left in too long it could lead to embolization.
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-2143-2020. 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.