The Recall Desk

FDA (Devices) recall action 87539

Boston Scientific Corporation recalled 2 products on 2021-04-21

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
2021-04-21
Critical
0
Units
115

Why these products were recalled

The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and 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.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2021-04-21

    Boston Scientific Recalls MAMBA Microcatheters for Labeling Errors

    Boston Scientific is recalling 63 MAMBA Microcatheters due to incorrect labeling and packaging. The devices were distributed nationwide and internationally.

    Product
    MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
    Category
    Distribution
    26 states
  • ModerateFDA (Devices)··2021-04-21

    Boston Scientific Recalls MAMBA Flex 135 Microcatheters for Labeling Errors

    Boston Scientific is removing specific batches of MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.

    Product
    MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
    Category
    Distribution
    26 states