Spectranetics recalls Bridge Occlusion Balloon REF 590-001 due to potential blood clot formation if left in blood vessels too long. All users should minimize balloon time in vasculature to prevent embolization.
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.
Spectranetics is recalling a specific type of medical balloon used in procedures. If left in blood vessels for too long, it could cause blood clots that might lead to serious complications like embolization.
The balloon can cause blood clots to form in blood vessels if left in place for long durations. This risk is especially concerning for procedures where the balloon is used for extended periods without proper monitoring, potentially leading to embolization.
Healthcare professionals using this balloon for procedures like lead extraction may be affected. Those who use the balloon for extended periods without monitoring are at higher risk.
This product is labeled as Bridge Occlusion Balloon REF 590-001 with Sheath Compatibility 12F and Guidewire Compatibility 0.035 in. It was sold as a single unit with specific dimensions and is for medical use only.
Verify if your balloon has the model number REF 590-001 with Sheath Compatibility 12F and Guidewire Compatibility 0.035 in.
The recall states that the risk is related to prolonged use, not improper use. When used correctly with monitoring, the risk is minimized.
The recall does not specify a time limit, but it emphasizes minimizing the time the balloon remains in the vasculature to reduce clot risk.
The recall does not require immediate discontinuation; users are advised to minimize usage time and monitor for potential clot formation.
We’ve drafted a message you can send Spectranetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2143-2020 — Spectranetics Spectranetics Hello, I own a Spectranetics that is covered by recall Z-2143-2020 from Spectranetics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
