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U.S. Department of Health and Human Services

Class 2 Device Recall PENTARAY NAV HighDensity Mapping Catheter

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 Class 2 Device Recall PENTARAY NAV HighDensity Mapping Cathetersee related information
Date Initiated by FirmMay 17, 2017
Create DateDecember 07, 2017
Recall Status1 Terminated 3 on December 15, 2020
Recall NumberZ-0212-2018
Recall Event ID 77529
510(K)NumberK120425 K123837 
Product Classification Catheter,intracardiac mapping,high-density array - Product Code MTD
ProductPENTARAY NAV High-Density Mapping Catheter.
Code Information Product code (Product Description) (GTIN): D-1282-07-S (NAV ECO 7FR, F, 4-4-4) (10846835012217), D-1282-08-S (NAV ECO 7FR, F, 2-6-2) (10846835012224), D-1282-09-S (NAV ECO 7FR, F, 1-8-1) (10846835012231), D-1282-10-S (NAV ECO 7FR, D, 4-4-4) (10846835012248), D-1282-11-S (NAV ECO 7FR, D, 2-6-2) (10846835012255), D-1282-12-S (NAV ECO 7FR, D, 1-8-1) (1846835012262).
Recalling Firm/
Manufacturer		 Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale CA 91706-2006
Manufacturer Reason
for Recall		Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
FDA Determined
Cause 2		Other
ActionRecall Notification letter, dated 04/14/2016, and Acknowledgement Form was sent to customers via express mail on 05/17/2017. Instructions included to read and follow Labeling Correction Notice carefully, provide the notice to anyone in the facility that should be aware, sign and return the Acknowledgement Form, and to maintain awareness of the correction.
Quantity in Commerce73,796 units total
DistributionNationwide Distributed internationally to Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Republic of Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Oman, People's Republic of China, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.
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 = MTD
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