Spectranetics Bridge Occlusion Balloon Catheter Recalled for Guidewire Issues
Spectranetics is recalling Bridge Occlusion Balloon catheters because the guidewire may not pass through the device, potentially delaying treatment.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, which mandates a severity score of at least 4 according to the rubric.
Plain-English summary
Spectranetics Corporation is recalling 2,356 units of the Bridge Occlusion Balloon catheter. The device is used to temporarily occlude the superior vena cava to prevent blood loss during lead extraction surgeries. The recall is due to a possible inability to pass the guidewire through the Bridge device, which could result in a potential delay of treatment.
The affected product is Model Number 590-001. The recall includes specific lots: FMN17B13A, FMN17C08A, FMN17C28A, FMN17D07A, FMN47D12A, FMN17D19A, FMN17D27A, FMN17E02A, FMN17E23A, FMN17E31A, FMN17E31B, FMN17F06A, FMN17F20A, FMN17F21A, FMN17G12A, FMN17G18A, FMN17H03A, FMN17H04A, FMN17H05A, FMN17H10A, FMN17H12A, FMN17H15A, FMN17H17A, FMN17H29A, FMN17J28A, and FMN17K02A.
The affected units were distributed worldwide, including the United States (nationwide) and countries such as Australia, Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Israel, Italy, Kuwait, Netherlands, Norway, Poland, South Africa, Sweden, Switzerland, and the United Kingdom. The FDA has classified this as a Class I recall.
The recalled product
- Product
- 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 Usage: It is a device used to occlude the vessel and prevent blood loss as the p
- Manufacturer
- Spectranetics Corporation
- Category
- Medical Device — Catheter
- Affected units
- 2,356
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number 590-001
- Lots FMN17B13A
- FMN17C08A
- FMN17C28A
- FMN17D07A
- FMN47D12A
- FMN17D19A
- FMN17D27A
- FMN17E02A
- FMN17E23A
- FMN17E31A
- FMN17E31B
- FMN17F06A
- FMN17F20A
- FMN17F21A
- FMN17G12A
- FMN17G18A. Additional lots: FMN17H03A
- FMN17H04A
- FMN17H05A
- FMN17H10A
Distribution
Distributed nationwide across the United States.
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