The Recall Desk

FDA (Devices) recall action 81747

Boston Scientific Corporation recalled 3 products on 2019-01-16

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
2019-01-16
Critical
0
Units
3,846

Why these products were recalled

Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.

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

  • LowFDA (Devices)··2019-01-16

    Boston Scientific Recalls IntellaTip MiFi Ablation Catheters in Japan

    Boston Scientific is recalling 1,282 IntellaTip MiFi Open-Irrigated Ablation Catheters in Japan due to unapproved resin material variations.

    Product
    IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2019-01-16

    Boston Scientific Recalls IntellaNav Ablation Catheters in Japan

    Boston Scientific is recalling IntellaNav MiFi Open-Irrigated Ablation Catheters in Japan due to unapproved resin material variations.

    Product
    IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2019-01-16

    Boston Scientific Recalls Blazer Ablation Catheters Due to Resin Changes

    Boston Scientific is recalling 1,282 Blazer Open-Irrigated Ablation Catheters in Japan because resin sub-supplier changes caused material variations not reflected in internal documentation.

    Product
    Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli
    Category
    Distribution
    0 states