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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Zuma Guide Catheter

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 Class 2 Device Recall Medtronic Zuma Guide Cathetersee related information
Date Initiated by FirmJune 08, 2011
Create DateJune 26, 2015
Recall Status1 Terminated 3 on April 17, 2012
Recall NumberZ-2754-2011
Recall Event ID 59111
510(K)NumberK010579 K990707 
Product Classification Catheter, percutaneous - Product Code DQY
ProductMedtronic 6F Zuma Guide Catheter with AL 1.5 Curve with side holes Catalog Number: Z26AL15SH The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
Code Information Lot # : 0005199588
Recalling Firm/
Manufacturer		 Medtronic Vascular
35-37A Cherry Hill Drive
Danvers MA 01923-2565
For Additional Information ContactSame
978-777-0042
Manufacturer Reason
for Recall		Mislabeled; Product labeled as 6F Zuma Guide with AL 1.5 curve with side holes may contain a 5F Zuma Catheter with SAL 1.0 curve
FDA Determined
Cause 2		Labeling Change Control
ActionThe firm, Medtronic, sent an "Urgent Medical Device Recall Notice(for US)" letter dated June 7, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to segregate the product so that it will not be used. A Medtronic Sales Representative will visit the customers to account for all units they received and initiate a credit as appropriate. If you have any questions, please call (978) 739-0371 or (978) 739-3259.
Quantity in Commerce5 units
DistributionNationwide distribution: USA including states of: CA, FL, and MA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DQY
510(K)s with Product Code = DQY
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