Colorado Springs, CO, United States
Spectranetics Corporation recalls
7 recalls recorded since 2018, most recently on 10 January 2025. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)5
Terminated or completed2
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 10 January 2025
- Reason
- 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 device in vessel after deployment, which may cause failure to resolve dissection, migration of implant, bailout stenting, reintervention, unintended removal of tack devices, and ischemia.
- Distribution
- Distribution US nationwide and countries of: NL, DE, NL, AU, IT, CH, GB, and AT
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1070-2025
- Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90c
Ongoing Class II Medical devices
- Recall started
- 25 November 2024
- Reason
- 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for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.
- Distribution
- U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, ILIN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD TN, TX, UT, VA, WA, WI, and WV. O.U.S.: Australia, Belgium, Brazil, China, Croatia, Cyprus, Czech Republic, Denmark, France, Ger
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0680-2025
- Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW 423-001 / 989930000
Ongoing Class II Medical devices
- Recall started
- 15 November 2023
- Reason
- Incorrect product labeling. Exterior product box label does not match internal pouch label.
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0509-2024
- 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 414-1
Ongoing Class II Medical devices
- Recall started
- 14 October 2022
- Reason
- 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 of treatment delay and/or treatment beyond initial scope and/or unable to treat patient.
- Distribution
- US: LA, MO, TN, CA, NC, PA, HI, AZ, CO, OK, FL, TX, MN, MI, VA, CT, NY, MD, IL, NJ, MA, KS, ME, AR, IA, IN, GA, ID, OR. OUS: DE, GB, ES, SE, IT, RS, GR, IN, FR, IL, DK, SA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0221-2023
- Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads.
Ongoing Class II Medical devices
- Recall started
- 1 June 2022
- Reason
- 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.
- Distribution
- US: 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 TX VA OUS: Saudi Arabia, Denmark, France, Greece, India, Italy, Netherlands, Serbia, Spain, Sweden, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1351-2022
- Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
Terminated Class II Medical devices
- Recall started
- 31 March 2020
- Terminated
- 31 October 2022
- Reason
- There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. All users, such as those performing lead extraction cases may not be aware of this risk. It was determined that current labeling is insufficient to ensure all potential users minimize the time the balloon remains in vasculature. If left in too long it could lead to embolization.
- Distribution
- US: Nationwide OUS: Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, Jordan, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2143-2020
- Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Marking, Sterile EO, UDI:
Terminated Class II Medical devices
- Recall started
- 7 December 2018
- Terminated
- 27 October 2020
- Reason
- The incorrect outer carton box was used for the product.
- Distribution
- Distribution was made to IA, MI, and NJ. There was government distribution. There was no military/foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0576-2020
- Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.