The Recall Desk

FDA (Devices) recall action 67712

Biocardia, Inc. recalled 2 products on 2014-04-02

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
2014-04-02
Critical
0
Units
5,082

Why these products were recalled

Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.

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.

1–2 of 2

  • HighFDA (Devices)··2014-04-02

    BioCardia Recalls Morph AccessPro Steerable Introducers Due to Particulate Risk

    BioCardia, Inc. is recalling Morph AccessPro Steerable Introducers because particulates in the inner lumen could cause an embolic event.

    Product
    Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2014-04-02

    BioCardia Morph AccessPro Steerable Introducer Recalled for Particulate Risk

    BioCardia is recalling Morph AccessPro Steerable Introducers due to potential particulates in the inner lumen that could cause an embolic event.

    Product
    Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other th
    Category
    Distribution
    0 states