The Recall Desk

FDA (Devices) recall action 77431

Boston Scientific Corporation recalled 2 products on 2017-07-12

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2017-07-12
Critical
0
Units
71

Why these products were recalled

Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon

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.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2017-07-12

    Boston Scientific Retrieval Balloon Catheter Recalled for Labeling Error

    Boston Scientific is recalling 39 units of the Extractor Pro RX-S Retrieval Balloon Catheter because the label incorrectly identifies the injection location.

    Product
    Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300
    Category
    Distribution
    2 states