Z-0758-2016Class II

2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy...

Name: Z-0758-2016 2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy...
Creator: Spectranetics Corp.
Published: 2016-01-15
License: https://open.fda.gov/license/

Spectranetics Corp. / initiated 2016-01-15 / Terminated / root cause: labeling and UDI

FDA source

Spectranetics Corp. began a recall of 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... on 2016-01-15. FDA classified it as Class II and gives the reason as "The product is labeled with an expiration date that is past its shelf life". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0758-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-15
Posted: 2016-02-05
Terminated: 2017-03-02
Recalling firm: Spectranetics Corp.
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, 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 code: MCW Catheter, Peripheral, Atherectomy
Reason for recall: The product is labeled with an expiration date that is past its shelf life.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Spectranectics sent a Medical Device Field Action letter dated January 15, 2016 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and set aside the affected product and contact Customer Service at 1-800-231-0978 to arrange a product exchange. Customers were asked to document the return on the enclosed Field Action Acknowledgement and Receipt Form. Customers with additional questions were instructed to contact their local Spectranetics sales representative. For questions regarding this recall call 719-447-2318.
Quantity in commerce: 8 units
Distribution: Nationwide distribution to Florida, North Carolina and Pennsylvania.
Product codes and lots: Lot CMP15J28A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0758-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0758-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-05

Product code MCW

K152181Class IITurbo-Power Laser Atherectomy CatheterSpectranetics, Inc. / cleared 2015-11-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)