Class 2 Device Recall ERIC Retrieval Device

• Date Initiated by Firm: August 05, 2024
• Date Posted: September 17, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3157-2024
• Recall Event ID: 95151
• 510(K)Number: K211120
• Product Classification: Catheter, thrombus retriever - Product Code NRY
• Product: 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.
• Code Information: Model Number: ER173020-US UDI-DI code: 00810170018831 Lot/Batch Numbers: 0000280707 0000281277 0000282616 0000337055 0000339787 0000341352 0000346638 0000347204 0000347518 0000369548 0000373878 0000383975 0000388574 0000390920 0000408227 0000413356 0000483914 0000509754 0000552788 0000556936 0000565975 0000584166 0000595486 0000605157 0000610234 0000616881 0000644624 0000648880 0000650593 Model Number: ER174030-US UDI-DI code: 00810170018848 Lot/Batch Numbers: 0000279433 0000281276 0000281278 0000282116 0000283271 0000337041 0000338960 0000342289 0000345185 0000345946 000034154 0000347296 0000364249 0000367420 0000372400 0000375208 0000385910 0000391720 0000394172 0000399765 0000402617 0000406053 0000412461 0000468600 0000472204 0000479549 0000488883 0000548672 0000554916 0000561944 0000563812 0000578999 0000584167 0000588191 0000599947 0000602913 0000619853 0000622476 0000630060 0000655111 Model Number: ER176044-US UDI-DI code: 00810170018862 Lot/Batch Numbers: 0000280790 0000181279 0000281275 0000336496 0000337865 0000340323 0000342830 0000347509 0000354010 0000354790 0000355704 0000361497 0000368172 0000374160 0000387557 0000389821 0000394759 0000401148 0000405396 0000409331 0000466714 0000470240 0000478434 0000481899 0000503647 0000504822 0000556934 0000558955 0000558957 0000563811 0000575805 0000578998 0000582277 0000592294 0000605158 0000619854 0000626526 0000651121
• Recalling Firm/ Manufacturer: MICROVENTION INC.; 35 Enterprise; Aliso Viejo CA 92656
• For Additional Information Contact: Terrence Callahan; 949-899-7194
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 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 terrence.callahan@microvention.com
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NRY