Spectranetics Bridge Occlusion Balloon Recalled for Thrombus Formation Risk
Spectranetics is recalling Bridge Occlusion Balloons because current labeling is insufficient to warn users about the risk of thrombus formation if the device remains in the vasculature for long durations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a hazard (thrombus/embolization) is identified, but the source text does not report any specific illnesses or injuries, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Spectranetics Corporation is recalling Bridge Occlusion Balloons (REF 590-001) due to a potential risk of thrombus formation. The recall is driven by a determination that current labeling is insufficient to ensure that all potential users minimize the time the balloon remains in the vasculature.
The source text notes that users performing lead extraction cases may not be aware of this specific risk. If the balloon is left in the vasculature for too long, it could lead to embolization. The recall covers all lots of the product.
The product was distributed nationwide in the United States and in numerous international locations, including Australia, Canada, and various European countries. The source text does not specify specific actions for consumers or healthcare providers beyond the context of the labeling deficiency.
The recalled product
- Product
- Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Marking, Sterile EO, UDI: 00813132024666
- Manufacturer
- Spectranetics Corporation
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 (1)
- All lots
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Spectranetics Corporation
See all →- CriticalVascular Tack Endovascular System recalled for deployment and migration risks
FDA (Devices) · 2025-02-26
- HighLaser Atherectomy Catheter Recalled for Marker Band Detachment Risk
FDA (Devices) · 2024-12-25
- ModerateSpectranetics Turbo-Elite Atherectomy Catheters recalled due to labeling mismatch
FDA (Devices) · 2023-12-20
- HighPhilips Laser System may enter non-recoverable error state
FDA (Devices) · 2022-11-23
- ModeratePhilips LAS-100 Laser System may not operate due to detected hardware failure
FDA (Devices) · 2022-07-20
Same hazard · thrombus formation
See all →- SevereReprocessed Electrophysiology Catheters Recalled for Residual Particles
FDA (Devices) · 2026-07-08
- SevereAbiomed Impella CP Set with SmartAssist 10th Generation Introducer Kit Recall
FDA (Devices) · 2026-07-01
- SevereAbiomed Impella CP Introducer Kit Recalled for Thrombus Risk
FDA (Devices) · 2026-07-01
- HighCook Inc. Recalls Zenith Alpha Spiral-Z Endovascular Leg Grafts
FDA (Devices) · 2020-03-04
Similar recalls
- SevereSpectranetics Bridge Occlusion Balloon Catheter Recalled for Guidewire Issues
FDA (Devices) · 2017-10-04
- ModerateSpectranetics Recalls Medical Devices Due to Compromised Sterile Packaging
FDA (Devices) · 2016-12-07
- LowSpectranetics AngioSculpt Balloon Catheter Recalled for Incorrect Outer Carton
FDA (Devices) · 2019-12-04
- ModerateStryker FlowGate2 Balloon Guide Catheter Recalled for Diameter Defect
FDA (Devices) · 2018-08-08
- ModerateBoston Scientific Recalls 4.0mm Flextome Cutting Balloon Devices
FDA (Devices) · 2013-09-11
- ModerateLeMaitre Aortic Occlusion Catheter Recalled for Incorrect Size Labeling
FDA (Devices) · 2019-09-11