ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy devi
Summary
The FDA issued a Class II for ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval by MICROVENTION INC.. Reason: Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expira.
Details
Source
Device Recall
External ID
Z-3157-2024
Action Date
2024-09-25
Status
Ongoing
Category
device
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.
Lot/Code Info: 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
Quantity Affected: 1,370 devices
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-05
Company
Aliso Viejo, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 257 device recalls issued in the same week, part of 403 device-related FDA actions this month.
MICROVENTION INC. has 18 FDA actions in our database, including 11 recalls and 7 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MICROVENTION INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MICROVENTION INC. have FDA actions?
MICROVENTION INC. has 18 FDA actions in our database, including 11 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3157-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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