PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22
Medical device recall Z-2372-2020. Published in FDA’s Enforcement Report on Jun 24, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 24, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 48 states named
- 435590 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
435590 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 2,000 characters
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 17626991L 17626992L 17626999L 17627001L 17627002L 17627004L 30155766L 30155767L 30155769L 30155773L 30155778L 30161076L 30161087L 30161091L 30161095L 30161096L 30163666L 30163668L 30163674L 30164145L 30164147L 17388298L 17388451L 17388452L 17626996L 17626997L 17627000L 17627094L 17627096L 17627097L 17627098L 17627099L 17627101L 17627102L 17627103L 17627104L 17627105L 17627106L 17627107L 30001259L 30001261L 30003199L 30003200L 30003202L 30003204L 30003208L 30003209L 30003210L 30003211L 30003212L 30003214L 30003216L 30003217L 30155469L 30155765L 30155768L 30155770L 30155771L 30155772L 30155774L 30155775L 30155776L 30155777L 30155779L 30155780L 30155781L 30157761L 30157762L 30157763L 30159846L 30161078L 30161082L 30161083L 30161086L 30161089L 30161090L 30161092L 30161094L 30161371L 30164146L 30164148L 30164150L 17627095L 17627100L 17627108L 17627420L 17627423L 30001252L 30001253L 30001254L 30001255L 30001256L 30001257L 30001258L 30001260L 30003201L 30003203L 30003205L 30003213L 17362543L 17392724L 17392726L 17627419L 17627421L 17627424L 30159581L 30161085L 30163670L 30163672L 30164149L 30164708L 30164710L…
FDA’s list runs to 161,749 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
48 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 22, 2020.
- FDA classified it on Jun 16, 2020.
- FDA’s Enforcement Report published it on Jun 24, 2020.
- FDA terminated it on Dec 15, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- BIOSENSE WEBSTER, of IRVINE, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 161,749 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.