# FDA recall Z-2372-2020

> **BIOSENSE WEBSTER** · Class II · device recall initiated 2020-04-22.

## 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 for recall

Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI IL, VA,, NE, OK, NJ, CT, KS, HI, CO, ND, RI, ID, MS, VT, DC and WV.       	  The countries of (EMEA, APAC, LATAM, US, Canada)  including: NZ,BE,DE,PL,SI,TR,HU,CO,KR,CL,PE,AU,BR,CA,CN,HK,ID,JP,MY,MX,PH,RU,SG,TW,TH,IL,AT,FR,GR,DE,IE,IT,PL,NL,PT,ES,SE,DK,NO,FI,CH,GB,RO,SI,HR,CZ,TR,ZA,AE,BR,ID,BE,PA,CR,CL,NZ,HK,RU,GR,NL,EG,QA,LU,NL,CH,AT,IE,CY.    See Attachments 2 & 3 for a distribution list including all domestic and foreign consignees of the device, addresses and phone numbers and the dates and number of devices distributed to each such consignee.

## Key facts

- **Recall number:** Z-2372-2020
- **Recalling firm:** BIOSENSE WEBSTER
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-22
- **Report date:** 2020-06-24
- **Termination date:** 2022-12-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** IRVINE, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2372-2020

## Citation

> AI Analytics. FDA recall Z-2372-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-2372-2020. Source: US FDA. Licensed CC0.

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