Events

Recall of Device Recall Catheter introducer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biocardia, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67492
  • Event Risk Class
    Class 2
  • Event Number
    Z-0991-2014
  • Event Initiated Date
    2014-02-07
  • Event Date Posted
    2014-02-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125554
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Introducer, catheter - Product Code DYB
  • Reason
    Tyvek packaging may be worn, causing loss of package integrity.
  • Action
    Sales Representative called each affected hospital on February 7, 2014, to notify them of the recall. BioCardia has initiated a recall of Morph AccessPro due to a potential compromise of the sterile barrier. Use of this product may result in patient infection. Sales representatives contacted hospital sites identified in Attachment 3 by telephone. Script provided as follows: "BioCardia has initiated a recall of Morph Access Pro due to a potential compromise of the sterile barrier. Use of this product may result in patient infection. Our records indicate that we sold you. The recall is limited to these units in this lot sold to you. We would like to confirm if you still have the unit(s). If you do, we ask that you quarantine the unit(s) and our customer service department will contact you to coordinate the return of the unit(s)." For further questions please call (650) 226-0133.

Device

Device Recall Catheter introducer
  • Model / Serial
    Catalog number MAP690; Lot numbers 01162 and 01186.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of FL, MA, WY. OH, MI and KS.
  • Product Description
    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 dilation catheters, guidewires and other therapeutic devices may be introduced into the peripheral vasculature.
  • Manufacturer
    Biocardia, Inc.

Manufacturer

Biocardia, Inc.
  • Manufacturer Address
    Biocardia, Inc., 125 Shoreway Rd Ste B, San Carlos CA 94070-2718
  • Manufacturer Parent Company (2017)
    BioCardia, Inc.
  • Source
    USFDA