Recall Z-1302-2014 ยท DYB Introducer, Catheter
Biocardia, Inc.
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.
| Date | Mar 27, 2014 (initiated Mar 3, 2014) |
| Status | Terminated |
| Reason | Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event. |
| Root cause | Other |
| 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 |
| Quantity | ~2541 units - both catalog numbers. |
| Distribution | Worldwide Distribution: US (nationwide) and country of: Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090999 | BIOCARDIA MORPH SHEATH GUIDE Biocardia, Inc., Apr 15, 2009 |