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.
데이터 추가 비고
Introducer, catheter - Product Code DYB
원인
Firm discovered the potential for particulates in the inner lumen of morph access pro steerable introducer, which could result in am embolic event.
조치
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.
Worldwide Distribution: US (nationwide) and country of: Israel.
제품 설명
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.