Spectranetics Recalls
13 recalls on record · February 17, 2016 to February 26, 2025 · Medical Devices
Recalls by year
16
17
19
20
22
23
24
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 26, 2025Medical DevicesFDA
Spectranetics Corporation recalls Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,
Hazard: 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.
December 25, 2024Medical DevicesFDA
Spectranetics Corporation recalls Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 m
Hazard: 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for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.
December 20, 2023Medical DevicesFDA
Spectranetics Corporation recalls Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy C
Hazard: Incorrect product labeling. Exterior product box label does not match internal pouch label.
November 23, 2022Medical DevicesFDA
Spectranetics Corporation recalls Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular syst
Hazard: 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.
July 20, 2022Medical DevicesFDA
Spectranetics Corporation recalls Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60H
Hazard: 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.
June 3, 2020Medical DevicesFDA
Spectranetics Corporation recalls Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length
Hazard: 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.
December 4, 2019Medical DevicesFDA
Spectranetics Corporation recalls Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-251
Hazard: The incorrect outer carton box was used for the product.
October 4, 2017Medical DevicesFDA
Spectranetics Corporation recalls Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Leng
Hazard: Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.
August 9, 2017Medical DevicesFDA
Spectranetics Corporation recalls Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use i
Hazard: 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.
December 7, 2016Medical DevicesFDA
Spectranetics Corporation recalls Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including
Hazard: Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
December 7, 2016Medical DevicesFDA
Spectranetics Corporation recalls ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009 The Laser Cat
Hazard: Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
December 7, 2016Medical DevicesFDA
Spectranetics Corporation recalls Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-00
Hazard: Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
February 17, 2016Medical DevicesFDA
Spectranetics Corp. recalls 2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a
Hazard: The product is labeled with an expiration date that is past its shelf life.