The Recall Desk

Manufacturer

Biocardia, Inc.

3 recalls in our database name Biocardia, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
1
Most recent
2014-04-02

Of the 3 recalls from Biocardia, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (33%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • SevereFDA (Devices)·Z-1301-2014·2014-04-02

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1302-2014·2014-04-02

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0991-2014·2014-02-26

    Biocardia Recalls Morph Accesspro Steerable Introducers Due to Packaging Wear

    Biocardia is recalling 11 units of Morph Accesspro Steerable Introducers because worn Tyvek packaging may cause loss of package integrity.

    Product
    MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilati
    Category
    Medical Device
    Distribution
    6 states