The Recall Desk

FDA (Devices) recall action 75617

Spectranetics Corporation recalled 3 products on 2016-12-07

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2016-12-07
Critical
0
Units
18,638

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Devices)··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
    Distribution
    0 states
  • ModerateFDA (Devices)··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
    Distribution
    0 states
  • ModerateFDA (Devices)··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
    Distribution
    0 states