PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only… — Class II medical device recall Z-2371-2020
Terminated recall by BIOSENSE WEBSTER, reported 2020-06-24, distributed nationwide. Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create
| Recall number | Z-2371-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BIOSENSE WEBSTER, IRVINE, CA, United States |
| Recall initiated | 2020-04-22 |
| Classified | 2020-06-16 |
| Reported by FDA | 2020-06-24 |
| Terminated | 2022-12-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| UPC / GTIN / UDI-DI | 10846835009576, 10846835009583, 10846835009590, 10846835009606, 10846835009613, 10846835009620 |
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 for recall
Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2371-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.