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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 2 of 12

Device	Model / Reference	Registries	Class	Status
Lld™ #3	518-020AA	FDA UDI	Class II	Active
Quick-Cross™Extreme™	518-090AA	FDA UDI	Class II	Active
AngioSculpt RX PTCA	2200-3520	FDA UDI	Class III	Active
SightRail™	555-513	FDA UDI	Class II	Unknown
Lld Ez™	518-067	FDA UDI	Class II	Unknown
Quick-Cross™Select	518-081AA	FDA UDI	Class II	Active
Turbo-Elite™	420-006AA	FDA UDI	Class II	Active
AngioSculpt®PTCA Scoring Balloon Catheter	2027-3515	FDA UDI	Class III	Unknown
VisiSheath™	501-012	FDA UDI	Class II	Unknown
Excimer Laser System	CVX-300-P	FDA UDI	Class III	Active
Stellarex	AB35SX040080080	FDA UDI	Class III	Active
SLS II Laser Sheath	500-001	FDA UDI	Class III	Active
Quick-Access™	519-005AA	FDA UDI	Class II	Active
Turbo-Power™	420-050	FDA UDI	Class II	Active
TightRail Mini™	540-009AA	FDA UDI	Class II	Active
TightRail Mini	540-011	FDA UDI	Class II	Active
AngioSculpt®PTCA Scoring Balloon Catheter	2027-3510	FDA UDI	Class III	Active
Stellarex	AB35SX060150080	FDA UDI	Class III	Active
VisiSheath™	501-114	FDA UDI	Class II	Unknown
AngioSculpt®PTCA Scoring Balloon Catheter	2001-3520	FDA UDI	Class III	Active
Turbo-Elite™	420-159	FDA UDI	Class II	Unknown
AngioSculpt®	2216-25100-A	FDA UDI	Class II	Active
SightRail™	550-013	FDA UDI	Class II	Unknown
Quick-Cross™Extreme™	518-086	FDA UDI	Class II	Unknown
GlideLight™	500-302	FDA UDI	Class III	Unknown
Elca™	110-001AA	FDA UDI	Class III	Active
SLS II Laser Sheath	500-012	FDA UDI	Class III	Active
Stellarex	AB35SX040100080	FDA UDI	Class III	Active
AngioSculpt®PTCA Scoring Balloon Catheter	2001-3010	FDA UDI	Class III	Active
SightRail™	555-511	FDA UDI	Class II	Unknown
Quick-Cross™	518-065	FDA UDI	Class II	Unknown
Quick-Cross™Select	518-093AA	FDA UDI	Class II	Active
Turbo-Elite™	410-154	FDA UDI	Class II	Unknown
AngioSculpt RX PTCA	2200-2520	FDA UDI	Class III	Active
VisiSheath™	501-216	FDA UDI	Class II	Unknown
AngioSculpt®PTCA Scoring Balloon Catheter	2027-2020	FDA UDI	Class III	Active
Stellarex	AB35SX060200135	FDA UDI	Class III	Active
Stellarex	AB35SX060100080	FDA UDI	Class III	Active
Quick-Cross™	518-032	FDA UDI	Class II	Unknown
Quick-Cross™Extreme™	518-076AA	FDA UDI	Class II	Active
SLS II Laser Sheath	500-013	FDA UDI	Class III	Active
TightRail™	545-511	FDA UDI	Class II	Unknown
GlideLight™	500-301	FDA UDI	Class III	Unknown
Stellarex	AB35SX040200080	FDA UDI	Class III	Active
TightRail™	545-513AA	FDA UDI	Class II	Active
Stellarex	AB35SX050150080	FDA UDI	Class III	Active
Quick-Cross™Select	518-087AA	FDA UDI	Class II	Active
Quick-Cross™	518-037	FDA UDI	Class II	Unknown
Elca™	110-001AB	FDA UDI	Class III	Active
AngioSculpt®PTCA Scoring Balloon Catheter	2001-2510	FDA UDI	Class III	Active

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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.