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.
Recall
- Recall Number
- Z-3157-2024
- Event Number
- 95151
- Firm
- MICROVENTION INC.
- FEI Number
- 3013556777
- Product Code
- NRY
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- August 5, 2024
- Posted
- September 17, 2024
- Address
- 35 Enterprise, Aliso Viejo, CA, 92656
Description
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.
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.
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 product in accordance with the instructions below: 1. Review Inventory MicroVention's records indicate that you have received an impacted lot. Please review your inventory based on the lot number (See Attachment #1 ). 2. Representative Inventory Trade Out Your MicroVention Representative will be coming to trade out your inventory as soon as possible to ensure you have correctly labeled product. During this time, you can safely use the product on your shelf, as there is no risk of it reaching its three-year expiration date before we perform the swap. 3. Inform and Forward Recall Notice Inform all individuals within your organization of the recall and if the device(s) was transferred, forward the recall notice to any organizations that may have received the affected products. 4. Return Product Please complete and return the "CUSTOMER ACKNOWLEDGMENT FORM" via email recalls@microventi on.com or in the return envelope provided to the contact below. For questions/assistance needed, contact Post-Market Surveillance at 949-899-7194 or email [email protected]
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.
1,370 devices