Recall Z-2371-2020 ยท MTD Catheter, Intracardiac Mapping, High-Density Array
BIOSENSE WEBSTER
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 hear
| Date | Apr 22, 2020 |
| Status | Terminated |
| Reason | Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map. |
| 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 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120425 | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER Biosense Webster, Inc., May 24, 2012 |