Reported Oct 4, 2017 · Terminated
Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working…
Spectranetics Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.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?
- Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only
- Product UsageIt is a device used to occlude the vessel and prevent blood loss as the physician preps for surgery resulting from an SVC tear complication of a lead extraction case. It is used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage
- Lot codes and dates
Model Number 590-001Lots FMN17B13AFMN17C08AFMN17C28AFMN17D07AFMN47D12AFMN17D19AFMN17D27AFMN17E02AFMN17E23AFMN17E31AFMN17E31BFMN17F06AFMN17F20AFMN17F21AFMN17G12AFMN17G18A
- Additional lots
FMN17H03AFMN17H04AFMN17H05AFMN17H10AFMN17H12AFMN17H15AFMN17H17AFMN17H29AFMN17J28AFMN17K02A
- Amount recalled
- 2,356 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.
Using this product could cause serious injury, illness or death — stop using it now.
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