# FDA recall Z-2143-2020

> **Spectranetics Corporation** · Class II · device recall initiated 2020-03-31.

## 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.

## Distribution

US:  Nationwide  OUS:  Australia, Austria, Belgium, Canada, Croatia,  Cyprus,  Czech Republic,  Denmark,  Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, Jordan, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, The Netherlands, and the United Kingdom of Great Britain and Northern Ireland

## Key facts

- **Recall number:** Z-2143-2020
- **Recalling firm:** Spectranetics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-31
- **Report date:** 2020-06-03
- **Termination date:** 2022-10-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Colorado Springs, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2143-2020

## Citation

> AI Analytics. FDA recall Z-2143-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2143-2020. Source: US FDA. Licensed CC0.

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