Z-2863-2017Class II

Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated...

Name: Z-2863-2017 Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated...
Creator: Spectranetics Corporation
Published: 2017-06-06
License: https://open.fda.gov/license/

Spectranetics Corp. / initiated 2017-06-06 / Terminated / root cause: design

FDA source

Spectranetics Corporation began a recall of Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, including atherectomy... on 2017-06-06. FDA classified it as Class II and gives the reason as "Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Catheters to become loose or disengaged rom the catheter when the device is in use in an off-label manner". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2863-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-06
Posted: 2017-07-14
Terminated: 2021-07-08
Recalling firm: Spectranetics Corp.
Product: Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions
Product code: MCW Catheter, Peripheral, Atherectomy
Reason for recall: Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Catheters to become loose or disengaged rom the catheter when the device is in use in an off-label manner.
Root cause tag: design
FDA root cause: Device Design
Action: Spectranetics sent a Field Safety Notice letter via certified mail on June 7, 2017, to all customers who have ordered the affected model numbers since 23May2016 reiterating the risks associated with off-label use of the device (i.e., not activating the laser within a stent and not until all contrast media is flushed from the treatment area). The product continues to meet specifications and does not need to be returned. Customers with questions were encouraged to call their local Spectranetics Sales Representative or Spectranetics Customer Service Department. Customer Service can be reached by phone at 800-231-0978 (Option 2), by fax at 877-447-2022, or by email at [email protected]. Customer Service is available Monday thru Friday, From 7AM-5PM MST.
Distribution: Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, Hawaii and Puerto Rico Foreign distribution to Bahrain, Brazil, Canada, Italy, Japan, and Netherlands
Product codes and lots: Model Number 414-159 Catheter Diameter 1.4mm, Model Number 417-156 Catheter Diameter 1.7mm, and Model Number 420-159 Catheter Diameter 2.0mm.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2863-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2863-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-08-02

Product code MCW

K170059Class IISpectranetics Turbo-Elite Laser Atherectomy CathetersSpectranetics, Inc. / cleared 2017-04-07

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)