The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the inf
FDA device recall Z-1252-2024 · posted 2024-03-04 · Open, Classified
Recall details
- Recalling firm
- Micro Therapeutics, Inc.
- Reason for recall
- European version of microcatheter were distributed within US which contain a different "Indications for Use".
- Action taken
- On January 11, 2024, Medtronic Neurovascular issued a "Urgent: Medical Device Recall" Medtronic ask consignees to take the following action: 1. Do not use any impacted product. Remove and quarantine all unused impacted product in your inventory. 2. Return the impacted products to Medtronic. Your Medtronic representative may assist in facilitating the return of product, as necessary. If an alternative product is needed, your Medtronic representative can assist you with identifying a suitable replacement product. 3. Complete and return the Customer Confirmation form enclosed with this letter acknowledging that you have received this information.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- MFE
- Quantity affected
- 82 units
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KS, MA, MD, MI, MO, NC, ND, NE, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI.
- Date initiated
- 2024-01-11
- Date posted
- 2024-03-04
- Location
- Irvine, CA
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