Z-2371-2020Class II

PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO -

Name: Z-2371-2020 PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO -
Creator: Biosense Webster
Published: 2020-04-22
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2020-04-22 / Terminated / root cause: labeling and UDI

FDA source

BIOSENSE WEBSTER began a recall of PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter... on 2020-04-22. FDA classified it as Class II and gives the reason as "Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2371-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-22
Posted: 2020-06-16
Terminated: 2022-12-15
Recalling firm: Biosense Webster Inc
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.
Product code: MTD Catheter, Intracardiac Mapping, High-Density Array
Reason for recall: Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On 4/22/2020 the firm issued an "URGENT Medical Device Correction" letter via UPS/certified mail, informing them that as a result of 3 complaints in 2019 in which a catheter became entrapped in the cardiac valvular apparatus while the user was attempting to create an electroanatomic map, leading to the need for surgical intervention for removal, the firm is performing a correction to the products. The Notification Letter informs customers: Following are learnings that users of this product should be aware of to avoid or address entrapment: " Repeated rotation of the catheter near the valvular apparatus may result in the entanglement of the product spines and further rotation could result in entrapment, leading to the need for surgical intervention. " A common use scenario for repeated rotation leading to entanglement may occur during mapping of the right ventricle and accessing of the right ventricular outflow tract using clockwise rotation. Caution should be exercised with manipulation to avoid spine entanglement with valvular structures. " Entanglement of the catheter can be identified by resistance felt by the user and a lack of movement of the spines during manipulation, which can be seen via the CARTO 3 System or by fluoroscopy. The device may appear in a broom-like configuration with entangled spines pointing in a single direction. With opposite manipulation (e.g. counterclockwise rotation for initial clockwise rotation), it may be possible to free the entangled device for safe removal. " Do not use excessive force to remove the device when entangled or entrapped as it may lead to damage to the cardiac structures or to the device. The firm is instructing customers: 1. Please maintain awareness of this letter and pass it on to anyone in your facility that needs to be informed. 2. Please complete, sign, and return the Business Reply Form. We have communicated this information to the applicable regulatory authorities. Method of Notification/M
Quantity in commerce: 0 units (Products were not manufactured from 2016 and later)
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2371-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2371-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-16
Z-2372-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-16

Product code MTD

K120425Class IIPentaray Nav High-Density Mapping CatheterBiosense Webster, Inc. / cleared 2012-05-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)