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 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-1302-2014
- Quantity
- ~2541 units - both catalog numbers.
- 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 MAP690 -lot numbers: 1051 1063 1083 1106 1119 1137 1138 1140 1146 1148 1151 1154 1160 1162 1183 1186
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.