Medical Thrombectomy Device Recalled for Incorrect Expiration Dates
MicroVention is recalling 1,370 ERIC Retrieval Devices due to labeling errors showing incorrect expiration dates (5 years instead of actual 3 years). Devices with mislabeled shelf life may be used beyond their true expiration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II device labeling error where incorrect expiration dates could result in use of devices beyond their true shelf life, risking device integrity and effectiveness in critical acute stroke treatment. No adverse events have been reported.
Plain-English summary
MicroVention Inc. is recalling 1,370 ERIC Retrieval Devices (model numbers ER173020, ER174030, and ER176044) nationwide. The devices are mechanical thrombectomy systems designed to restore blood flow by removing clots in patients suffering from acute ischemic stroke.
The recall was initiated because product labels list incorrect expiration dates, stating a shelf life of 5 years when the actual expiration date is 3 years. This labeling error could result in healthcare providers using devices beyond their true expiration date, potentially compromising device integrity and effectiveness.
The affected devices were distributed nationwide to hospitals and healthcare facilities in 16 states: Arkansas, California, Florida, Indiana, Louisiana, Massachusetts, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, and Virginia.
Patients and healthcare providers who have received these devices should verify the actual expiration date through MicroVention and not rely on the label dates. Healthcare facilities should contact the manufacturer for guidance on affected lot numbers and proper device management.
The recalled product
- 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.
- Manufacturer
- MICROVENTION INC.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 1,370
Distribution
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