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Spectranetics Corporation Recalls

7 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Spectranetics Corporation.

7Total Recalls
2Critical
20,900Units Affected
Jan 10, 2025Most Recent
All Recalls

Every Spectranetics Corporation Recall

Sorted by most recent. Click any recall for full details.

7 recalls
CriticalFDA
Spectranetics Corporation
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm...
Medical Implants·2,939 affected·Jan 10, 2025
High RiskFDA
Spectranetics Corporation
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
Medical Devices·105 affected·Jun 1, 2022
High RiskFDA
Spectranetics Corporation
Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon O...
Medical Devices·0 affected·Mar 31, 2020
High RiskFDA
Spectranetics Corporation
Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. ...
Surgical Devices·3 affected·Dec 7, 2018
CriticalFDA
Spectranetics Corporation
Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon ...
Surgical Devices·2,356 affected·Aug 7, 2017
High RiskFDA
Spectranetics Corporation
Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including perioperative oc...
Medical Devices·873 affected·Oct 31, 2016
High RiskFDA
Spectranetics Corporation
Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 Th...
Surgical Devices·14,624 affected·Oct 31, 2016