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
    67712
  • Event Risk Class
    Class 2
  • Event Number
    Z-1301-2014
  • Event Initiated Date
    2014-03-03
  • Event Date Posted
    2014-03-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126128
  • 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
    Firm discovered the potential for particulates in the inner lumen of morph access pro steerable introducer, which could result in am embolic event.
  • Action
    The firm, BioCardia, Inc., sent an "URGENT-VOLUNTARY MEDICAL DEVICE RECALL" letter dated March 3, 2014 its customers, hospital's Director of Risk Management, via USPS mail and priority mail to Cardiac Catheterization Laboratory. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory; quarantine the product; return the product to BioCardia and contact Customer Service at 650-226-0148 to coordinate product return; in the event you no longer have this device as a result of further distribution, identify the purchaser and notify them at once of this recall; and complete and return the enclosed MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form via FAX to 650-631-3731 or mail to: BioCardia, Inc., 125 Shoreway Road, Suite B, San Carlos, CA 94070 as soon as possible. If you have any questions, call the Vice President, Quality Assurance at 650-226-0143.

Device

Device Recall Catheter Introducer
  • Model / Serial
    Catalog number MAP645 -  Lot numbers:  1037  1048  1055  1059  1069  1073  1074  1079  1092  1095  1115  1118  1121  1125  1128  1130  1134  1147  1155  1164  1168  1169  1173  1177  1184  1190
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and country of: Israel.
  • Product Description
    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 therapeutic devices that 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