FDA Medical Device Recalls (openFDA)
Spectranetics Corporation: 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
- Recall number
- Z-2863-2017
- Recalling firm
- Spectranetics Corporation
- 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
- Status
- Terminated
- Initiated
- 2017-06-06
- Posted
- 2017-07-14
- Terminated
- 2021-07-08
- Reason
- 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
- 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 customer.service@spnc.com. Customer Service is available Monday thru Friday, From 7AM-5PM MST.
- Quantity
- not on file
- 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
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K170059"]
- PMA numbers
- not on file
- Product code
- MCW
- Firm FEI
- 3007284006
- Firm city
- Colorado Springs
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28