Spectranetics Recalls Medical Devices Due to Compromised Sterile Packaging
Spectranetics is voluntarily recalling the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon because their outer sterile packaging may be compromised.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary field action addressing potentially compromised sterile packaging, which is a low-risk contamination or packaging issue without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Spectranetics Corporation has announced a voluntary field action for three medical devices: the Turbo Elite Atherectomy Catheter, the ELCA Coronary Atherectomy Catheter, and the Bridge Occlusion Balloon. The Bridge Occlusion Balloon is used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.
The recall is being conducted due to potentially compromised integrity of the outer sterile packaging for these devices. The source text does not specify the exact mechanism of the packaging failure or the specific risks associated with the compromised integrity.
The affected Bridge Occlusion Balloon units (Model 590-001) were distributed worldwide, including in the United States (nationwide and Puerto Rico) and internationally to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, and Thailand. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled devices.
The recalled product
- Product
- Bridge Occlusion Balloon. Model: 590-001 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.
- Manufacturer
- Spectranetics Corporation
- Affected units
- 873
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 (12)
- FMN16E11A
- FMN16E18A
- FMN16E25A
- FMN16F01A
- FMN16F08A
- FMN16F15A FMN16F22A
- FMN16G13A
- FMN16G19A
- FMN16G25A
- FMN16H04A
- FMN16H23A
- FMN16J27A
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Spectranetics Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →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 · packaging integrity
See all →- HighCRE Wireguided 18-20mm 240cm medical devices recalled for sterile breach
FDA (Devices) · 2026-07-08
- ModerateCRE Wireguided 8-10mm 240cm Medical Device Recall Notice
FDA (Devices) · 2026-07-08
- LowPopping Boba RTD Peach Oolong Tea recalled for packaging integrity
FDA (Food) · 2026-04-08
- LowPopping Boba RTD Strawberry Dragon Fruit Oolong Tea packaging integrity issue
FDA (Food) · 2026-04-08
- LowPopping Boba Ready-to-Drink Mango Passion Fruit Green Tea Recall
FDA (Food) · 2026-04-08