CLASS II Device recall · Reported 17 Feb 2016 · FDA Enforcement Report
Turbo-Power OTW, Manual recalled by Spectranetics
Spectranetics is recalling Turbo-Power OTW, Manual, distributed nationwide in the US. The recall was initiated on 15 Jan 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0758-2016
- FDA event ID
- 73098
- Recalling firm
- Spectranetics, Colorado Springs, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jan 2016
- FDA classified
- 5 Feb 2016
- Reported
- 17 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 15 Jan 2016 | Recall initiated by company | |
| 5 Feb 2016 | Classified by FDA | +21 days |
| 17 Feb 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product is labeled with an expiration date that is past its shelf life.
Product as listed by the FDA
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, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300" Excimer Laser System and is a Type CF device, Defibrillation proof. Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA). Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5 mm or greater in diameter. The device is comprised of three parts: the working length of the catheter shaft (also the applied part), the motor drive unit (MDU), and the proximal laser shaft which connects the catheter fiber optics to the CVX-300" Excimer Laser System.
Where it was distributed
Nationwide distribution to Florida, North Carolina and Pennsylvania.
Questions about this recall
Why was it recalled?
The product is labeled with an expiration date that is past its shelf life.
Which lots are affected?
Lot CMP15J28A
Where was it sold?
Nationwide distribution to Florida, North Carolina and Pennsylvania.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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