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Spectranetics Corporation FDA Recalls
5 recalls on file across devices, 1 of them Class I and 5 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,Class IJan 10, 2025Use of Tack Endovascular system, designed to treat acute dis |
| Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mClass IINov 25, 2024Due to complaints received for the marker band detaching fro |
| Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy CClass IINov 15, 2023Incorrect product labeling. Exterior product box label does |
| Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular systClass IIOct 14, 2022Laser System may detect Error 106 or Error 108 System Failur |
| Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HClass IIJun 1, 2022The LAS-100 Laser system may detect an inoperable hardware c |