Spectranetics Recalls Expired 2.3mm Turbo-Power Laser Atherectomy Catheters
Spectranetics Corp. is recalling 8 units of 2.3mm Turbo-Power OTW Manual laser atherectomy catheters because they are past their expiration date.
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 2/5 (Moderate).
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 classified as FDA Class II and involves a labeling/shelf-life error without reported injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Spectranetics Corp. is recalling 8 units of the 2.3mm Turbo-Power OTW, Manual, Model No 423-050 laser atherectomy catheters. The recall is due to the product being labeled with an expiration date that is past its shelf life.
The affected units are from Lot CMP15J28A and were distributed nationwide to Florida, North Carolina, and Pennsylvania. The Turbo-Power System is a sterile, single-use, prescription-only device used for peripheral atherectomy with the CVX-300 Excimer Laser System.
Healthcare providers and facilities should stop using the affected units and contact Spectranetics Corp. for further instructions.
The recalled product
- Product
- 2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use…
- Manufacturer
- Spectranetics Corp.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 8
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)
- Lot CMP15J28A
Distribution
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