The Recall Desk

FDA (Devices) recall action 78897

Cardiovascular Systems Inc recalled 2 products on 2018-02-14

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
2018-02-14
Critical
0
Units
16

Why these products were recalled

Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production.

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)··2018-02-14

    Cardiovascular Systems Recalls Peripheral Diamondback Atherectomy Systems Due to Labeling Error

    Cardiovascular Systems Inc. is recalling eight units of the Peripheral Diamondback 1.50 Solid OAD system because labeling for two lots was potentially switched during production.

    Product
    Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
    Category
    Distribution
    9 states
  • ModerateFDA (Devices)··2018-02-14

    Cardiovascular Systems Recalls Peripheral Diamondback Atherectomy Systems Due to Labeling Error

    Cardiovascular Systems Inc. is recalling eight units of the Peripheral Diamondback 1.25 Solid OAD system because labeling for two lots was potentially switched during production.

    Product
    Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
    Category
    Distribution
    9 states