FDA Device recall Z-2371-2020
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Densi…
- FDA Device
- Class II
- terminated
- Published 2020-06-24
On 2020-06-24 the FDA classified a Class II recall of PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Densi… by Biosense Webster, citing mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2371-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-22 |
| Published | 2020-06-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biosense Webster |
| Distribution | US |
Product
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
Reason
Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
Identifiers
| code_info | This field action includes all lots of the following product codes: D-1282-07, D-1282-08, D-1282-10 and D-1282-11…This field action includes all lots of the following product codes: D-1282-07, D-1282-08, D-1282-10 and D-1282-11 The other product codes listed in the 806 report for the PENTARAY NAV High-Density Mapping Catheter: D128201, D128202, D128203, D128204, D128205, D128206 are out of scope of this recall because they were not manufactured during the period that is subject to this field action (2016 or later). Product Code Product Description GTIN Number D-1282-01-S PENTARAY¿ NAV, 7FR, F, 4-4-4 10846835009576 D-1282-02-S PENTARAY¿ NAV, 7FR, F, 2-6-2 10846835009583 D-1282-03-S PENTARAY¿ NAV, 7FR, F, 1-8-1 10846835009590 D-1282-04-S PENTARAY¿ NAV, 7FR, D, 4-4-4 10846835009606 D-1282-05-S PENTARAY¿ NAV, 7FR, D, 2-6-2 10846835009613 D-1282-06-S PENTARAY¿ NAV, 7FR, D, 1-8-1 10846835009620 Note - the firm is including the above code information for products that will be distributed to new customers. No Lot Numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Biosense Webster
- VARIPULSE Bi-Directional Ablation Catheter REF D141201
FDA Device · Class I · 2025-03-12 · Biosense Webster - CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibili…
FDA Device · Class II · 2024-03-20 · Biosense Webster - Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
FDA Device · Class II · 2023-04-12 · Biosense Webster - Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
FDA Device · Class II · 2023-04-12 · Biosense Webster - CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501
FDA Device · Class II · 2022-09-14 · Biosense Webster
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2371-2020%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.