Spectranetics recalls
5 official recalls and safety alerts involving Spectranetics since 2022-07, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Spectranetics or the relevant agency.
- 2025-02-26
USSpectranetics Corporation recalls Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm),…
Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in problems with deployment and stability of…
FDA · DeviceSpectranetics CorporationDistribution US nationwide and countries of: NL, DE, NL, AU, IT, CH, GB, and ATOfficial notice →- 2024-12-25
- US
Spectranetics Corporation recalls Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 /…
Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.
FDA · DeviceSpectranetics CorporationU.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, ILIN, KS, KY,…Official notice → - 2023-12-20
- US
Spectranetics Corporation recalls Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW…
Incorrect product labeling. Exterior product box label does not match internal pouch label.
FDA · DeviceSpectranetics CorporationU.S Nationwide - Worldwide Distribution: US Distribution: AL, AR, AZ, CA, CO,…Official notice → - 2022-11-23
- US
Spectranetics Corporation recalls Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the…
Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. The user will not be able to proceed until the error is cleared. May result in initiation…
FDA · DeviceSpectranetics CorporationUS: LA, MO, TN, CA, NC, PA, HI, AZ, CO, OK, FL, TX, MN, MI, VA, CT, NY, MD,…Official notice → - 2022-07-20
- US
Spectranetics Corporation recalls Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until code is cleared.
FDA · DeviceSpectranetics CorporationUS: AR AZ CA CO CT FL GA HI IA IL IN KS LA MA MD ME MI MN MO NC NJ NY OK PA TN…Official notice →