Recall Z-3157-2024 ยท NRY Catheter, Thrombus Retriever
MICROVENTION INC.
ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by effectively removing clots from occlusive vasculature in patients suffering from acute ischemic stroke.
| Date | Sep 17, 2024 (initiated Aug 5, 2024) |
| Status | Open, Classified |
| Reason | Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date. |
| Root cause | Under Investigation by firm |
| Action | On 08/08/2024, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via FedEx Overnight Certified to customers informing them that it has identified a labeling discrepancy with the ERIC Retrieval Devices sold in the United States. the discrepancy is, the expiration date on the packaging shows a five year expiration while the correct date should reflect a three-year expiration. Customers are instructed to: Commencing in September 2024 your MicroVention Representative will be in your facility to swap out your current inventory with correctly labeled product. Alternatively, you can return the |
| Quantity | 1,370 devices |
| Distribution | U.S. Nationwide distribution in the states of AR, CA, FL, IN, LA, MA, MN, MO, NC, NJ, NY, OH, PA, SC, TX and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211120 | ERIC Retrieval Device MicroVention, Inc., Mar 31, 2022 |