Recall Z-1591-2016
Biosense Webster, Inc. · initiated April 14, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.
Codes / lots: 16050993L 16052415L 16050242L 16049660L 16054298L 16053514L 16054297L 16052414L 16053513L 16053516L 16050992L 15990830L 16012853L 16047426L 16054299L 16048721L 17055438L 17058924L 17064807L 17066297L 17055454L 17069067L 17064806L 17069961L 17069964L 17051780L 17069065L 17069066L 17052759L 17052760L 17053741L 17065103L 17053740L 17053742L 17059593L 17059595L 17058925L 17058929L 17059594L 17058930L 17059596L 17059592L 17055455L 17055437L 17050534L 17066833L 17066832L 17103225L 17100630L 17103709L 17104144L 17100633L 17187339L 17187331L 17186424L 17187338L 17187334L 17183074L 17173411L 17172912L 17172049L 17186423L 17186426L 17173416L 17183072L 17186422L 17169225L 17166017L 17173131L 17182426L 17181315L 17182429L 17177947L 17177950L 17173419L 17173414L 17177952L 17148553L 17148570L 17152997L 17165843L 17165844L 17165845L 17176640L 17177946L 17182419L 17182416L 17176183L 17177228L 17182424L 17183068L 17183066L 17182423L 17182420L 17183069L 17183070L 17183071L 17172068L 17172069L 17173137L 17173445L 17173133L 17173443L 17171926L 17172070L 17173134L 17176182L 17173417L 17173418L 17177945L 17177951L 17176180L 17176181L 17175535L 17182425L 17172050L 17172910L 17172045L 17190460L…
Reason for recall
Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves.
FDA-determined cause: Use error
Action taken
The firm, Biosense Webster, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 4/14/2016 to its customers. The letter described the product, problem and actions to be taken. The letter informs customers that the recall action is NOT a product removal, and that they may continue to use PENTARAY Catheters in accordance with the updated contraindication as stated in the recall letter. Customers are instructed to read and follow the Labeling Correction Notice carefully; pass on this letter to anyone in your facility that needs to be informed; maintain a copy of this letter with the PENTARAY Catheters, and sign and return the attached ACKNOWLEDGEMENT FORM immediately by email: BWI_FA_Coordinator@its.jnj.com, fax: 909-839-8514 or mail: Biosense Webster, Inc., Attn: FCA Coordinator,15715 Arrow Highway, Irwindale, CA 91706. The updated the IFU to clarify the contraindication statement as follows: "Do not use PENTARAY Catheters in patients with prosthetic valves". For questions related to this medical device correction, please contact your BWI sales representative or call 909-839-8500.
Details
- Recall number
- Z-1591-2016
- Initiated
- April 14, 2016
- Terminated
- October 14, 2016
- Product code
- MTD – Catheter, Intracardiac Mapping, High-Density Array
- Quantity
- 59,672 units
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of: Canada, China, Hong Kong, Indonesia, India, Japan, Korea, Malaysia, New Zealand, Singapore, Thailand, Taiwan, United Arab Emirates, Austria, Belgium, Bulgaria, Switzerland, Czech Republic, Germany, Denmark, Algeria, Spain, Finland, France, United Kingdom, Greece, Hungary, Ireland, Israel, Iraq, Iceland, Italy, Latvia, Netherlands, Norway…
- Recalling firm
- Biosense Webster, Inc., Irwindale, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1590-2016 Class II | Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203…Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the… | 04/14/2016Terminated |