Recall Z-2372-2020 ยท MDT Elisa, Trichinella Spiralis
BIOSENSE WEBSTER
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
| 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 | 435590 units |
| 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
| K123837 | PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER Biosense Webster, Inc., Mar 5, 2013 |