Z-0509-2024Class II

Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser...

Name: Z-0509-2024 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser...
Creator: Spectranetics Corporation
Published: 2023-11-15
License: https://open.fda.gov/license/

Spectranetics Corp. / initiated 2023-11-15 / Open, Classified / root cause: packaging

FDA source

Spectranetics Corporation began a recall of Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006 Spectranetics... on 2023-11-15. FDA classified it as Class II and gives the reason as "Incorrect product labeling. Exterior product box label does not match internal pouch label". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0509-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-15
Posted: 2023-12-08
Recalling firm: Spectranetics Corp.
Product: Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.4 RX REF 414-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.7 OTW REF 417-152 The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.
Product code: MCW Catheter, Peripheral, Atherectomy
Reason for recall: Incorrect product labeling. Exterior product box label does not match internal pouch label.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On 11/15/2023, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via US Postal Service Certified Mail to customers informing them that as a result of 3 complaints received the firm became aware that exterior box labels were incorrectly labeled and did not match the interior product pouch label. Customers are instructed to: -Immediately check their product inventory and quarantine any potentially affected devices from the affected lots. -Do not open or use any products that have been identified with their inventory -Complete and return the Response Form within 30 days so that Philips can initiate the return and replacement process free of charge (based upon the completed Response Form) -Circulate the notice to all users and/or to any organization where the potentially affected devices may have been transferred -Send completed Response Forms via email to [email protected] For questions or further assistance, contact local Philips representative or Philips Image Guided Therapy Devices Customer Service at 1-800-231-0978, option 2.
Quantity in commerce: 1,239 catheters
Distribution: U.S Nationwide - Worldwide Distribution: US Distribution: AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, and WA Foreign Distribution: Germany, Italy, Poland and Spain
Product codes and lots: Model Number: 420-159 UDI code: 01)00813132024734(17)250614(10)FAZ23F06A Lot Number: FBH23F02A Model Number: 420-006 UDI code: (01)00813132024758(17)250622(10)FBA23F09A Lot Number: FBA23F09A Model Number: 414-159 UDI code: (01)00813132024727(17)250621(10)FBF23F05B Lot Number: FBF23F05B Model Number: 417-152 UDI code: (01)00813132024765(17)250623(10)FBH23F02A Lot Number: FAZ23F06A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0509-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0509-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-08

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)