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.
This recall has been terminated (originally issued March 27, 2014).
- Company
- Biocardia, Inc.
- Recall Initiated
- March 3, 2014
- Posted
- March 27, 2014
- Terminated
- June 19, 2014
- Recall Number
- Z-1301-2014
- Quantity
- ~2541 - both models
- Firm Location
- San Carlos, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
Distribution
Worldwide Distribution: US (nationwide) and country of: Israel.
Lot / Code Info
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
Root Cause
Other
Action Taken
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.