Recall Z-1213-2022 ยท MTD Catheter, Intracardiac Mapping, High-Density Array
Abbott
FIRMap" Catheter, 60mm Basket
| Date | Apr 28, 2022 |
| Status | Terminated |
| Reason | Incorrect product labeling. |
| Root cause | Process control |
| Action | The firm sent out a "MEDICAL DEVICE RECALL" notification letter dated 04/28/2022 via hand delivery to the US customers. OUS consignee notification is via hand delivery. A copy of the English version of the OUS letter is attached and this letter was translated into the appropriate languages for delivery. The letter instructs the consignee to stop using the remaining inventory, complete and return the acknowledgement form by email: EPCcompliance@abbott.com, and return all unused devices. Should you have questions about this issue, please contact your local Abbott Representative or Abbot Supp |
| Quantity | 40 units |
| Distribution | US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142182 | FRIMAP ADAPTER CONNECTOR (MAC) Topera, Inc., Sep 9, 2014 |