Spectranetics recalls
Spectranetics appears in 13 official U.S. recall notices indexed by RecallRadar, most recently on 2025-02-26.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 13 |
|---|---|
| Published | 2016-02-17 to 2025-02-26 |
| By agency | FDA Device (13) |
| By classification | Class II (11), Class I (2) |
| By status | terminated (8), ongoing (5) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, WA, WI, WV |
Recalls
- Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm,…
FDA Device · Class I · 2025-02-26 · Spectranetics
Reason: 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 dev… - Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 98993…
FDA Device · Class II · 2024-12-25 · Spectranetics
Reason: 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for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted. - Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 42…
FDA Device · Class II · 2023-12-20 · Spectranetics
Reason: Incorrect product labeling. Exterior product box label does not match internal pouch label. - Philips Laser System, REF: LAS-100
FDA Device · Class II · 2022-11-23 · Spectranetics
Reason: 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… - Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
FDA Device · Class II · 2022-07-20 · Spectranetics
Reason: 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. - Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Out…
FDA Device · Class II · 2020-06-03 · Spectranetics
Reason: 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 determine… - Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The…
FDA Device · Class II · 2019-12-04 · Spectranetics
Reason: The incorrect outer carton box was used for the product. - Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Ou…
FDA Device · Class I · 2017-10-04 · Spectranetics
Reason: Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment. - Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, incl…
FDA Device · Class II · 2017-08-09 · Spectranetics
Reason: 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. - Turbo Elite Atherectomy Catheter
FDA Device · Class II · 2016-12-07 · Spectranetics
Reason: 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 out… - ELCA Coronary Atherectomy Catheter
FDA Device · Class II · 2016-12-07 · Spectranetics
Reason: 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 out… - Bridge Occlusion Balloon
FDA Device · Class II · 2016-12-07 · Spectranetics
Reason: 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 out… - 2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy de…
FDA Device · Class II · 2016-02-17 · Spectranetics
Reason: The product is labeled with an expiration date that is past its shelf life.