Pentaray NAV High-density Mapping Catheter Electrode EA recall
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping…
Why was Pentaray NAV High-density Mapping Catheter Electrode EA recalled?
Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping…
- Recalling firm
- BIOSENSE WEBSTER
- Quantity
- 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.
- Recall date
- June 24, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)