Reported Dec 7, 2016 · Terminated
Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including…
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 Drive · Colorado Springs, CO · 80921-3617
Is this the product you have?
- Bridge Occlusion Balloon
- Model590-001 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
- Lot codes and dates
FMN16E11AFMN16E18AFMN16E25AFMN16F01AFMN16F08AFMN16F15A FMN16F22AFMN16G13AFMN16G19AFMN16G25AFMN16H04AFMN16H23AFMN16J27A
- Amount recalled
- 873 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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