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U.S. Department of Health and Human Services

Class 2 Device Recall Catheter introducer

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  Class 2 Device Recall Catheter introducer see related information
Date Initiated by Firm February 07, 2014
Date Posted February 19, 2014
Recall Status1 Terminated 3 on April 03, 2014
Recall Number Z-0991-2014
Recall Event ID 67492
510(K)Number K090999  
Product Classification Introducer, catheter - Product Code DYB
Product MORPH ACCESSPRO Steerable Introducer;
6F introducer, 90 cm working length:
Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic:
BioCardia Inc.
San Carlos, CA 94070

Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires and other therapeutic devices may be introduced into the peripheral vasculature.
Code Information Catalog number MAP690; Lot numbers 01162 and 01186.
Recalling Firm/
Manufacturer		 Biocardia, Inc.
125 Shoreway Rd Ste B
San Carlos CA 94070-2718
For Additional Information Contact Michael Kolber
650-226-0133
Manufacturer Reason
for Recall		 Tyvek packaging may be worn, causing loss of package integrity.
FDA Determined
Cause 2		 Process control
Action Sales Representative called each affected hospital on February 7, 2014, to notify them of the recall. BioCardia has initiated a recall of Morph AccessPro due to a potential compromise of the sterile barrier. Use of this product may result in patient infection. Sales representatives contacted hospital sites identified in Attachment 3 by telephone. Script provided as follows: "BioCardia has initiated a recall of Morph Access Pro due to a potential compromise of the sterile barrier. Use of this product may result in patient infection. Our records indicate that we sold you. The recall is limited to these units in this lot sold to you. We would like to confirm if you still have the unit(s). If you do, we ask that you quarantine the unit(s) and our customer service department will contact you to coordinate the return of the unit(s)." For further questions please call (650) 226-0133.
Quantity in Commerce 11 units
Distribution US Distribution including the states of FL, MA, WY. OH, MI and KS.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = BIOCARDIA, INC.
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