The Recall Desk

FDA (Devices) recall action 68373

Boston Scientific Corporation recalled 6 products on 2014-06-25

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2014-06-25
Critical
0
Units
5,808

Why these products were recalled

Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.

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.

1–6 of 6

  • ModerateFDA (Devices)··2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Distribution
    0 states