Spectranetics Turbo-Elite Atherectomy Catheters recalled due to labeling mismatch
Spectranetics Corporation is recalling 1,239 Turbo-Elite Laser Atherectomy Catheters due to incorrect labeling where the exterior product box label does not match the internal pouch label.
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: This is an FDA Class II recall involving a labeling discrepancy with no reported injuries or illnesses. The hazard is limited to product labeling rather than device malfunction, meeting the criteria for Moderate severity under the rubric.
Plain-English summary
Spectranetics Corporation is recalling 1,239 Turbo-Elite Laser Atherectomy Catheters in multiple configurations (models 420-159, 420-006, 414-159, and 417-152). These are medical devices indicated for treatment of arterial stenoses and occlusions. The devices have been distributed throughout the United States and internationally.
The recalled catheters have incorrect product labeling: the exterior product box label does not match the internal pouch label. No associated injuries or illnesses have been reported.
The affected devices were distributed to healthcare facilities across the United States and in Germany, Italy, Poland, and Spain. Patients and healthcare providers should verify their lot numbers against the FDA recall announcement. Those with affected products should contact Spectranetics Corporation for appropriate guidance.
The recalled product
- Product
- Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.4 RX REF 414-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1
- Manufacturer
- Spectranetics Corporation
- Hazard
- Affected units
- 1,239
Distribution
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