Spectranetics Corporation
Complete recall history across all FDA and CPSC categories — 12 total recalls
Spectranetics Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (12)
FDA medical device enforcement actions by Spectranetics Corporation
| Date | Product | Reason | Class |
|---|---|---|---|
| Jan 10, 2025 | Intact Vascular Tack Endovascular System, to treat vascular dissections with ... | Use of Tack Endovascular system, designed to treat acute dissections of inner... | Class I |
| Nov 25, 2024 | Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product ... | Due to complaints received for the marker band detaching from the distal tip ... | Class II |
| Nov 15, 2023 | Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Sp... | Incorrect product labeling. Exterior product box label does not match intern... | Class II |
| Oct 14, 2022 | Philips Laser System, REF: LAS-100. Used in minimally invasive interventiona... | Laser System may detect Error 106 or Error 108 System Failures that will caus... | Class II |
| Jun 1, 2022 | Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle depende... | The LAS-100 Laser system may detect an inoperable hardware component during p... | Class II |
| Mar 31, 2020 | Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guide... | There is a potential for thrombus formation on balloons prepped and staged in... | Class II |
| Dec 7, 2018 | Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diamet... | The incorrect outer carton box was used for the product. | Class II |
| Aug 7, 2017 | Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Gu... | Possible inability to pass the guidewire through the Bridge device, therefore... | Class I |
| Jun 6, 2017 | Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchang... | Potential for flouroscopially visible marker band at the tip of the Rapid Exc... | Class II |
| Oct 31, 2016 | ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-00... | Spectranetics Corporation announces a voluntary field action for the Turbo El... | Class II |
| Oct 31, 2016 | Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159,... | Spectranetics Corporation announces a voluntary field action for the Turbo El... | Class II |
| Oct 31, 2016 | Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the s... | Spectranetics Corporation announces a voluntary field action for the Turbo El... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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