Recall Z-3157-2024— MICROVENTION INC.
Class II · Ongoing
Class II FDA medical device recall by MICROVENTION INC., initiated 2024-08-05. It names one FDA 510(k) clearance: K211120. 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.. 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..
- Recalling firm
- MICROVENTION INC.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-05
- Firm location
- Aliso Viejo, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.