Recall Z-1590-2016
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 Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 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: 15798659L 15795833L 15805361L 15782835L 15793498L 15795840L 15808937L 15803354L 15801125L 15805364L 15808933L 15808940L 15790718L 15799746L 15800549L 15795194L 15795197L 15800489L 15814334L 15814875L 15811695L 15811699L 15815788L 15782017L 15801124L 15801127L 15799738L 15799744L 15819531L 15800485L 15804551L 15814337L 15814339L 15814869L 15811196L 15811200L 15816732L 15806214L 15820998L 15805358L 15825347L 15808939L 15784813L 15787804L 15825339L 15815350L 15819522L 15819524L 15819529L 15825880L 15809778L 15810494L 15814871L 15820209L 15820199L 15820207L 15820210L 15816738L 15820991L 15820993L 15821008L 15803346L 15805362L 15808934L 15825889L 15825893L 15828085L 15828089L 15795201L 15809773L 15816737L 15820994L 15805360L 15808932L 15808938L 15825342L 15825881L 15825887L 15825891L 15828086L 15828087L 15828088L 15828090L 15831087L 15803968L 15814332L 15822449L 15822451L 15826600L 15828094L 15825882L 15811195L 15811692L 15827318L 15815787L 15825348L 15835412L 15835415L 15820212L 15821738L 15822458L 15822463L 15826605L 15828092L 15831082L 15831085L 15832438L 15832441L 15833155L 15833156L 15833158L 15833160L 15833164L 15835566L 15835571L 15831852L 15831854L 15839707L 15839406L…
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-1590-2016
- Initiated
- April 14, 2016
- Terminated
- October 14, 2016
- Product code
- MTD – Catheter, Intracardiac Mapping, High-Density Array
- Quantity
- 13,912 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-1591-2016 Class II | Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209…Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the… | 04/14/2016Terminated |