Spectranetics recalls
Spectranetics appears in 13 official U.S. recall notices indexed by RecallRadar, most recently on 2025-02-26.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm,…
FDA Device · Class I · 2025-02-26 · Spectranetics - Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 98993…
FDA Device · Class II · 2024-12-25 · Spectranetics - Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 42…
FDA Device · Class II · 2023-12-20 · Spectranetics - Philips Laser System, REF: LAS-100
FDA Device · Class II · 2022-11-23 · Spectranetics - Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
FDA Device · Class II · 2022-07-20 · Spectranetics - Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Out…
FDA Device · Class II · 2020-06-03 · Spectranetics - Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The…
FDA Device · Class II · 2019-12-04 · Spectranetics - Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Ou…
FDA Device · Class I · 2017-10-04 · Spectranetics - Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, incl…
FDA Device · Class II · 2017-08-09 · Spectranetics - Turbo Elite Atherectomy Catheter
FDA Device · Class II · 2016-12-07 · Spectranetics - ELCA Coronary Atherectomy Catheter
FDA Device · Class II · 2016-12-07 · Spectranetics - Bridge Occlusion Balloon
FDA Device · Class II · 2016-12-07 · Spectranetics - 2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy de…
FDA Device · Class II · 2016-02-17 · Spectranetics