Reported Jun 3, 2020 · Terminated
Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working…
Spectranetics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spectranetics Corporation · 9965 Federal Dr · Colorado Springs, CO · 80921-3822
Is this the product you have?
Bridge Occlusion BalloonREF 590-001QTY 1Sheath Compatibility 12FGuidewire Compatibility 0.035 inWorking Length 90 cmBalloon Outer Diameter 31 mmBalloon Length 80 mmmRx ONLYCE MarkingSterile EO
- UDI00813132024666
- Lot codes and dates
- All lots
- Amount recalled
- N/A
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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