Spectranetics recalls

Spectranetics has 12 recalls on record with the FDA and USDA, the earliest in 2016 and the latest reported on 26 Feb 2025. 4 are still ongoing. The most frequent reason is sterility.

Total recalls12since 2016

Last 12 months0reported

Class I217% of total

Ongoing4latest 26 Feb 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 1 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 2 17%Class II 10 83%Class III 0 0%

Why spectranetics is recalled

Product types

By year

202518%
202318%
2022217%
202018%
201918%
2017217%
2016433%

Ongoing spectranetics recalls

4 active

Reported	Class	Recall	Company	Reason	Where
26 Feb 2025Device	CLASS I	Intact Vascular Tack Endovascular System recalled by Spectranetics	Spectranetics	Potency & Assay	Nationwide
20 Dec 2023Device	CLASS II	Turbo-Elite Laser Atherectomy Catheter 0 RX recalled by Spectranetics	Spectranetics	Packaging Defects	Nationwide
23 Nov 2022Device	CLASS II	Philips Laser System recalled by Spectranetics	Spectranetics	Device Malfunction	30 states
20 Jul 2022Device	CLASS II	Philips Laser System recalled by Spectranetics	Spectranetics	Other	23 states

All spectranetics recalls, newest first

12 total

Reported	Class	Recall	Company	Reason	Where
26 Feb 2025Device	CLASS I	Intact Vascular Tack Endovascular System recalled by Spectranetics	Spectranetics	Potency & Assay	Nationwide
20 Dec 2023Device	CLASS II	Turbo-Elite Laser Atherectomy Catheter 0 RX recalled by Spectranetics	Spectranetics	Packaging Defects	Nationwide
23 Nov 2022Device	CLASS II	Philips Laser System recalled by Spectranetics	Spectranetics	Device Malfunction	30 states
20 Jul 2022Device	CLASS II	Philips Laser System recalled by Spectranetics	Spectranetics	Other	23 states
3 Jun 2020Device	CLASS II	Bridge Occlusion Balloon recalled by Spectranetics	Spectranetics	Lead & Heavy Metals	Nationwide
4 Dec 2019Device	CLASS II	AngioSculpt PTCA Scoring Balloon Catheter recalled by Spectranetics	Spectranetics	Sterility	IA, MI, NJ
4 Oct 2017Device	CLASS I	Bridge Occlusion Balloon catheter, Sheath Compatibility 12F recalled	Spectranetics	Lead & Heavy Metals	Nationwide
9 Aug 2017Device	CLASS II	Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid recalled	Spectranetics	Other	40 states
7 Dec 2016Device	CLASS II	ELCA Coronary Atherectomy Catheter recalled by Spectranetics	Spectranetics	Sterility	Nationwide
7 Dec 2016Device	CLASS II	Turbo Elite Atherectomy Catheter recalled by Spectranetics	Spectranetics	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.