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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 11 of 12

Device	Model / Reference	Registries	Class	Status
AngioSculpt OTW PTA Scoring Balloon Catheter	2334-7040	EUDAMEDFDA UDI	Class IIa	Active
AngioSculpt OTW PTA Scoring Balloon Catheter	2155-3540	EUDAMEDFDA UDI	Class IIa	Active
TorqMax Sheath Grip Accessory	502-001	EUDAMEDFDA UDI	Class I	Active
VisiSheath Dilator Sheath	501-212	EUDAMEDFDA UDI	Class III	Active
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon	A35SX040150135	EUDAMED	Class III	Active
TightRail Rotating Dilator Sheath	545-511	EUDAMEDFDA UDI	Class III	Active
ELCA Coronary Laser Atherectomy Catheter	114-009	EUDAMEDFDA UDI	Class III	Active
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon	A35SX050040080	EUDAMED	Class III	Active
AngioSculpt OTW PTA Scoring Balloon Catheter	2039-3020	EUDAMEDFDA UDI	Class IIa	Active
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon	A35SX050120135	EUDAMED	Class III	Active
Quick-Cross Select Support Catheter	518-091	EUDAMEDFDA UDI	Class III	Active
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon	A35SX060100135	EUDAMED	Class III	Active
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon	A35SX050060080	EUDAMED	Class III	Active
Quick-Cross Support Catheter	518-034	EUDAMEDFDA UDI	Class III	Active
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon	A35SX040080135	EUDAMED	Class III	Active
Stellarex 0.014" OTW Drug-coated Angioplasty Balloon	AA14SX035040090	EUDAMED	Class III	Active
Quick-Cross Select Support Catheter	518-087	EUDAMED	Class III	Active
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon	A35SX040120135	EUDAMED	Class III	Active
Quick-Cross Extreme Support Catheter	518-082	EUDAMEDFDA UDI	Class III	Active
Stellarex 0.014" OTW Drug-coated Angioplasty Balloon	AA14SX020040090	EUDAMED	Class III	Active
Quick-Cross Support Catheter	518-038	EUDAMEDFDA UDI	Class III	Active
VisiSheath Dilator Sheath	501-216	EUDAMEDFDA UDI	Class III	Active
AngioSculpt PTCA RX Scoring Balloon Catheter	2200-3515	EUDAMEDFDA UDI	Class III	Active
AngioSculpt OTW PTA Scoring Balloon Catheter	2333-7040	EUDAMEDFDA UDI	Class IIa	Active
AngioSculpt OTW PTA Scoring Balloon Catheter	2216-25100	EUDAMEDFDA UDI	Class IIa	Active
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon	A35SX050150080	EUDAMED	Class III	Active
VisiSheath Dilator Sheath	501-114	EUDAMEDFDA UDI	Class III	Active
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon	A35SX040120080	EUDAMED	Class III	Active
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon	A35SX040080135	EUDAMED	Class III	Active
Quick-Cross Select Support Catheter	518-079	EUDAMEDFDA UDI	Class III	Active
Quick-Cross Support Catheter	518-037	EUDAMED	Class III	Active
AngioSculpt OTW PTA Scoring Balloon Catheter	2076-5020	EUDAMEDFDA UDI	Class IIa	Active
VisiSheath Dilator Sheath	501-116	EUDAMEDFDA UDI	Class III	Active
AngioSculpt OTW PTA Scoring Balloon Catheter	2105-6020	EUDAMEDFDA UDI	Class IIa	Active
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon	A35SX050080135	EUDAMED	Class III	Active
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon	A35SX050100135	EUDAMED	Class III	Active
AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating	2216-35100	EUDAMEDFDA UDI	Class IIa	Active
LLD #3 Lead Locking Device	518-020	EUDAMEDFDA UDI	Class IIa	Active
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon	A35SX060200135	EUDAMED	Class III	Active
Philips Laser System	LAS-100	EUDAMEDFDA UDI	Class IIb	Active
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon	A35SX060120135	EUDAMED	Class III	Active
AngioSculpt OTW PTA Scoring Balloon Catheter	2076-5040	EUDAMEDFDA UDI	Class IIa	Active
Bridge Occlusion Balloon	590-001	EUDAMEDFDA UDI	Class III	Active
AngioSculpt OTW PTA Scoring Balloon Catheter	2076-6020	EUDAMEDFDA UDI	Class IIa	Active
AngioSculpt OTW PTA Scoring Balloon Catheter	2216-30100	EUDAMEDFDA UDI	Class IIa	Active
Stellarex 0.014" OTW Drug-coated Angioplasty Balloon	AA14SX030040090	EUDAMED	Class III	Active
Stellarex 0.014" OTW Drug-coated Angioplasty Balloon	AA14SX030150090	EUDAMED	Class III	Active
LLD E Lead Locking Device	518-039	EUDAMED	Class IIa	Active
Quick-Cross Extreme Support Catheter	518-076	EUDAMEDFDA UDI	Class III	Active
Stellarex 0.014" OTW Drug-coated Angioplasty Balloon	AA14SX020150150	EUDAMED	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.