The Recall Desk

Manufacturer

Spectranetics Corporation

12 recalls in our database name Spectranetics Corporation as the manufacturing or recalling firm.

What the numbers show

Total
12
Critical
1
Severe
1
Most recent
2025-02-26

Of the 12 recalls from Spectranetics Corporation we have scored against our rubric, 1 (8%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (8%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–12 of 12

  • CriticalFDA (Devices)·Z-1070-2025·2025-02-26

    Vascular Tack Endovascular System recalled for deployment and migration risks

    Spectranetics' Intact Vascular Tack Endovascular System may fail to deploy properly or migrate in blood vessels, potentially causing ischemia and requiring additional intervention.

    Product
    Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90cm CE, REF: 154090042 (6F, 3.5 - 6.0mm), 135cm, REF: 15613
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0680-2025·2024-12-25

    Laser Atherectomy Catheter Recalled for Marker Band Detachment Risk

    Spectranetics is recalling the Turbo Elite Laser Atherectomy Catheter because the marker band can detach from the catheter tip and remain in the patient. This defect was identified through customer complaints.

    Product
    Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW 423-001 / 989930000591 / 2.3 mm OTW 425-011 / 989930000601 / 2.5 mm OTW 423-1
    Category
    Medical Device
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-0509-2024·2023-12-20

    Spectranetics Turbo-Elite Atherectomy Catheters recalled due to labeling mismatch

    Spectranetics Corporation is recalling 1,239 Turbo-Elite Laser Atherectomy Catheters due to incorrect labeling where the exterior product box label does not match the internal pouch label.

    Product
    Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.4 RX REF 414-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0221-2023·2022-11-23

    Philips Laser System may enter non-recoverable error state

    The Philips Laser System (REF: LAS-100) may experience system failures (Error 106 or 108) that prevent further treatment during cardiac procedures.

    Product
    Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads.
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-1351-2022·2022-07-20

    Philips LAS-100 Laser System may not operate due to detected hardware failure

    Spectranetics' Philips LAS-100 Laser System (105 units) may fail to start if the device detects an inoperable hardware component during power-up, requiring manual error code clearing before operation.

    Product
    Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-2143-2020·2020-06-03

    Spectranetics Bridge Occlusion Balloon Recalled for Thrombus Formation Risk

    Spectranetics is recalling Bridge Occlusion Balloons because current labeling is insufficient to warn users about the risk of thrombus formation if the device remains in the vasculature for long durations.

    Product
    Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Marking, Sterile EO, UDI: 00813132024666
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0576-2020·2019-12-04

    Spectranetics AngioSculpt Balloon Catheter Recalled for Incorrect Outer Carton

    Spectranetics Corporation is recalling three AngioSculpt PTCA Scoring Balloon Catheters because the incorrect outer carton box was used for the product.

    Product
    Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-3106-2017·2017-10-04

    Spectranetics Bridge Occlusion Balloon Catheter Recalled for Guidewire Issues

    Spectranetics is recalling Bridge Occlusion Balloon catheters because the guidewire may not pass through the device, potentially delaying treatment.

    Product
    Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. Product Usage: It is a device used to occlude the vessel and prevent blood loss as the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2863-2017·2017-08-09

    Spectranetics Turbo-Elite Laser Atherectomy Catheters Recalled for Marker Band Risk

    Spectranetics is recalling Turbo-Elite Laser Atherectomy Catheters because a marker band may become loose or disengaged when the device is used off-label.

    Product
    Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-0661-2017·2016-12-07

    Spectranetics Recalls Turbo Elite Atherectomy Catheters Due to Packaging Integrity

    Spectranetics is voluntarily recalling Turbo Elite Atherectomy Catheters and related devices because their outer sterile packaging may be compromised.

    Product
    Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0663-2017·2016-12-07

    Spectranetics Recalls Medical Devices Due to Compromised Sterile Packaging

    Spectranetics is voluntarily recalling the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon because their outer sterile packaging may be compromised.

    Product
    Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0662-2017·2016-12-07

    Spectranetics Recalls ELCA Coronary Atherectomy Catheters Due to Packaging Integrity

    Spectranetics is voluntarily recalling ELCA Coronary Atherectomy Catheters and related devices because their outer sterile packaging may be compromised.

    Product
    ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary art
    Category
    Medical Device
    Distribution
    Distributed nationwide