FDA Device recall Z-2372-2020
PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-D…
- FDA Device
- Class II
- terminated
- Published 2020-06-24
On 2020-06-24 the FDA classified a Class II recall of PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-D… 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-2372-2020 |
| 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 eco 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 | PENTARAY NAV eco High-Density Mapping Catheter: All Lots of the following product codes: D-1282-07, D-1282-08, D-1282…PENTARAY NAV eco High-Density Mapping Catheter: All Lots of the following product codes: D-1282-07, D-1282-08, D-1282-10 and D-1282-11 Product Code Product Description GTIN Number D-1282-07-S PENTARAY¿ NAV ECO 7FR, F, 4-4-4 10846835012217 Lot Number 30001176L 30003606L 30003607L 30001016L 30001251L 17625708L 30005207L 30005537L 30005089L 30005206L 30166349L 30166345L 30166346L 30166347L 30166348L 30166351L 17393341L 17630191L 17630192L 17630193L 17393342L 17393343L 17395423L 17630194L 17395888L 17397254L 17393340L 30338080L 30338081L 30009837L 30166350L 30338079L 17633498L 17633500L 30009839L 30009842L 30009843L 30009844L 30345912L 17633499L 30009838L 30009841L 30011828L 30011829L 30011830L 30011831L 30345911L 30345913L 17403221L 17404168L 17404171L 30173420L D-1282-08-S PENTARAY¿ NAV ECO 7FR, F, 2-6-2 10846835012224 Lot Number 17626989L 17626993L 17626995L 17626998L 176 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2372-2020%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.