FDA Device recall Z-1590-2016
Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray…
- FDA Device
- Class II
- terminated
- Published 2016-05-11
On 2016-05-11 the FDA classified a Class II recall of Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray… by Biosense Webster, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1590-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-14 |
| Published | 2016-05-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biosense Webster |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | 15798659L 15795833L 15805361L 15782835L 15793498L 15795840L 15808937L 15803354L 15801125L 15805364L 15808933L…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1590-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.