Agency classClass IOur severity:Severe FDA (Devices)·Z-3106-2017·Announced 2017-10-04

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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…
Manufacturer: Spectranetics Corporation
Category: Medical Device — Catheter
Hazard: device-malfunction
treatment-delay
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.

Same manufacturer · Spectranetics Corporation

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