Spectranetics Corp.: Medical Device Recall in 2016 - (Recall #: Z-0758-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 15, 2016

Date Posted: February 17, 2016

Recall Number: Z-0758-2016

Event ID: 73098

Reason for Recall:

The product is labeled with an expiration date that is past its shelf life.

Status: Terminated

Product Quantity: 8 units

Code Information:

Lot CMP15J28A

Distribution Pattern:

Nationwide distribution to Florida, North Carolina and Pennsylvania.

Voluntary or Mandated:

Voluntary: Firm initiated