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U.S. Department of Health and Human Services

Class 3 Device Recall Medtronic AVE

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  Class 3 Device Recall Medtronic AVE see related information
Date Initiated by Firm March 17, 2003
Date Posted May 09, 2003
Recall Status1 Terminated 3 on February 19, 2008
Recall Number Z-0800-03
Recall Event ID 25847
510(K)Number K981198  
Product Z2 Guiding Catheter 6 F JR3.5 SH
Item No. : Z26JR35SH
Code Information Lot Number: 122596
Recalling Firm/
Manufacturer		 Medtronic, Inc.
35-37A Cherry Hill Drive
Danvers MA 01923-2565
For Additional Information Contact Fred L. Boucher, R.A.C.
978-739-3116
Manufacturer Reason
for Recall		 The PTCA catheter is mislabeled: the curve style (Judkin Left vs. Judkin Right ) of the catheter may not correctly match the box label.
FDA Determined
Cause 2		 Other
Action Medtronic AVE notified the firm''s sales representatives on 3/17/03 by e-mail to retrieve affected product from the hospital and return it Danvers, MA. Each sales rep. is required to document the notification and accounting for the devices returned from the field.
Distribution AL, AR, KY, LA, MT, NH, NY, PA, WI Foreign: Japan, Hungary
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 = and Original Applicant = MEDTRONICS INTERVENTIONAL VASCULAR
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