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Spectranetics Corporation

United States·US-MF-000018632

Last updated September 17, 2026

Information

Country: United States
Address: 5055, Brandin Court , Fremont, United States
Website: n/a
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: n/a
PRRC Contact: David Horton
EUDAMED SRN: US-MF-000018632
FDA FEI Number: 3005462046
DUNS Number: 151047370

Catalogue (572)

Page 1 of 12

Device	Model / Reference	Registries	Class	Status
Bridge Occlusion Balloon	K203540	FDA 510(k)	Class II	Active
Tightrail Mini	K141131	FDA 510(k)	Class II	Active
Stellarex	AB35SX060120135	FDA UDI	Class III	Active
Stellarex	AB35SX060060080	FDA UDI	Class III	Active
AngioSculpt®	2237-40100-A	FDA UDI	Class II	Unknown
AngioSculpt®	2237-60100	FDA UDI	Class II	Unknown
AngioSculpt®PTCA Scoring Balloon Catheter	2027-2015	FDA UDI	Class III	Active
Turbo-Elite™	417-156AA	FDA UDI	Class II	Active
SightRail™	550-008	FDA UDI	Class II	Unknown
Stellarex	AB35SX040080135	FDA UDI	Class III	Active
Stellarex	AB35SX040120080	FDA UDI	Class III	Active
AngioSculpt	2216-20100	FDA UDI	Class II	Unknown
AngioSculpt®	2215-30100	FDA UDI	Class II	Active
Turbo Tandem™	472-110	FDA UDI	Class II	Unknown
Stellarex	AB35SX040040080	FDA UDI	Class III	Active
Turbo-Elite™	420-006	FDA UDI	Class II	Unknown
TightRail Mini™	540-011AA	FDA UDI	Class II	Active
Lld™ #1	518-018	FDA UDI	Class II	Unknown
Turbo-Booster™	518-043	FDA UDI	Class II	Unknown
Stellarex	AB35SX050060080	FDA UDI	Class III	Active
Elca™	110-002	FDA UDI	Class III	Unknown
AngioSculpt RX PTCA	2200-3020	FDA UDI	Class III	Active
AngioSculpt®PTCA Scoring Balloon Catheter	2027-3020	FDA UDI	Class III	Active
Turbo-Elite Laser Atherectomy Catheter	425-135-01	FDA UDI	Class II	Active
Stellarex	AB35SX050080080	FDA UDI	Class III	Active
Quick-Cross™Extreme™	518-078AA	FDA UDI	Class II	Active
Turbo-Booster™	518-063AA	FDA UDI	Class II	Active
Turbo-Power™	423-050	FDA UDI	Class II	Active
Turbo Elite™	425-135-01	FDA UDI	Class II	Unknown
AngioSculpt®	2215-35100	FDA UDI	Class II	Active
AngioSculpt®	2076‐5020-A	FDA UDI	Class II	Active
VisiSheath™	501-112	FDA UDI	Class II	Unknown
AngioSculpt®	2039-2010-A	FDA UDI	Class II	Unknown
Stellarex	AB35SX040120135	FDA UDI	Class III	Active
Stellarex	AB35SX060080135	FDA UDI	Class III	Active
AngioSculpt®	2290-40100-A	FDA UDI	Class II	Unknown
AngioSculpt®	2215-30100-A	FDA UDI	Class II	Unknown
Lld™ #1	518-018AA	FDA UDI	Class II	Active
TightRail™	545-509AA	FDA UDI	Class II	Active
Quick-Cross™Extreme™	518-092	FDA UDI	Class II	Unknown
TightRail™	545-513	FDA UDI	Class II	Unknown
Stellarex	AB35SX050200080	FDA UDI	Class III	Active
Stellarex	AB35SX060040135	FDA UDI	Class III	Active
AngioSculpt®PTCA Scoring Balloon Catheter	2001-2015	FDA UDI	Class III	Active
Quick-Cross™Extreme™	518-082	FDA UDI	Class II	Unknown
Turbo-Elite™	417-152AA	FDA UDI	Class II	Active
Turbo-Elite Laser Atherectomy Catheter	410-154	FDA UDI	Class II	Active
Lld™ #1	518-021AA	FDA UDI	Class II	Active
Stellarex	AB35SX050150135	FDA UDI	Class III	Active
Turbo-Elite™	417-156	FDA UDI	Class II	Unknown

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FDA Recalls (21)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 10, 2025	Z-1070-2025	—	open, classified	Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in problems with deployment and stability of device in vessel after deployment, which may cause failure to resolve dissection, migration of implant, bailout stenting, reintervention, unintended removal of tack devices, and ischemia.
Nov 25, 2024	Z-0680-2025	—	open, classified	Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.
Nov 15, 2023	Z-0509-2024	—	open, classified	Incorrect product labeling. Exterior product box label does not match internal pouch label.
Oct 14, 2022	Z-0221-2023	—	open, classified	Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. The user will not be able to proceed until the error is cleared. May result in initiation of treatment delay and/or treatment beyond initial scope and/or unable to treat patient.
Jun 1, 2022	Z-1351-2022	—	open, classified	The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until code is cleared.
Mar 31, 2020	Z-2143-2020	—	terminated	There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. All users, such as those performing lead extraction cases may not be aware of this risk. It was determined that current labeling is insufficient to ensure all potential users minimize the time the balloon remains in vasculature. If left in too long it could lead to embolization.
Dec 7, 2018	Z-0576-2020	—	terminated	The incorrect outer carton box was used for the product.
Aug 7, 2017	Z-3106-2017	—	terminated	Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.
Jun 6, 2017	Z-2863-2017	—	terminated	Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Catheters to become loose or disengaged rom the catheter when the device is in use in an off-label manner.
Oct 31, 2016	Z-0663-2017	—	terminated	Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
Oct 31, 2016	Z-0662-2017	—	terminated	Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
Oct 31, 2016	Z-0661-2017	—	terminated	Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
Jan 15, 2016	Z-0758-2016	—	terminated	The product is labeled with an expiration date that is past its shelf life.
Mar 13, 2012	Z-1395-2012	—	terminated	Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket.
Jul 18, 2011	Z-2952-2011	—	terminated	Packaging integrity may be compromised, thus sterility can not be assured.
Jul 18, 2011	Z-2951-2011	—	terminated	Packaging integrity may be compromised, thus sterility can not be assured.
Jul 1, 2010	Z-2190-2010	—	terminated	Guidewire lumen may be occluded, preventing guidewire insertion into the catheter.
Mar 16, 2009	Z-1264-2009	—	terminated	Catheter outer jacket may split during use.
Oct 15, 2008	Z-0903-2009	—	terminated	Catheter pouch was mislabeled with the wrong size.
Jul 4, 2008	Z-0976-2009	—	terminated	The catheter pouch label was incorrectly labeled with the wrong size.
Dec 10, 2007	Z-0698-2008	—	terminated	Mislabeling: Catheters were placed into mis-labeled inner pouches as REF Number 518-037, 135 cm--the exterior box labeling is correct as 90 cm.