Reported Dec 20, 2023 · Ongoing
Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy…
Spectranetics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spectranetics Corporation · 9965 Federal Dr · Colorado Springs, CO · 80921-3822
Is this the product you have?
8 of 8 products
| Model / number | Barcodes | Product as published |
|---|---|---|
420-159 | 00813132024734 | UDI code: 01)00813132024734(17)250614(10)FAZ23F06A |
| — | Lot Number: FBH23F02A | |
420-006 | 00813132024758 | UDI code: (01)00813132024758(17)250622(10)FBA23F09A |
| — | Lot Number: FBA23F09A | |
414-159 | 00813132024727 | UDI code: (01)00813132024727(17)250621(10)FBF23F05B |
| — | Lot Number: FBF23F05B | |
417-152 | 00813132024765 | UDI code: (01)00813132024765(17)250623(10)FBH23F02A |
| — | Lot Number: FAZ23F06A |
- Amount recalled
- 1,239 catheters
Where it was sold
Why it was recalled
Incorrect product labeling. Exterior product box label does not match internal pouch label.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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