CLASS II ONGOING Device recall · Reported 13 Mar 2024 · FDA Enforcement Report
The Apollo Onyx Delivery Microcatheter recalled by Micro Therapeutics
Micro Therapeutics is recalling The Apollo Onyx Delivery Microcatheter (Aomc) is a Dmso-compatible, single-lumen, end, distributed nationwide in the US. The recall was initiated on 11 Jan 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1252-2024
- FDA event ID
- 93922
- Recalling firm
- Micro Therapeutics, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Jan 2024
- FDA classified
- 4 Mar 2024
- Reported
- 13 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 11 Jan 2024 | Recall initiated by company | |
| 4 Mar 2024 | Classified by FDA | +53 days |
| 13 Mar 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
European version of microcatheter were distributed within US which contain a different "Indications for Use".
Product as listed by the FDA
The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories. The outer diameter surface of the catheter is hydrophilically coated to increase lubricity. The AOMC is designed to facilitate catheter retrieval in the event the catheter becomes entrapped within the vasculature. The distal section of the catheter incorporates a detachment zone that allows detachment of the distal tip when the force required to extract the catheter exceeds the force to detach the tip. The catheter has two radiopaque marker bands to visualize the position of the catheter and the detach zone area, one proximal to the detach zone and one at the distal end of the catheter.
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaConnecticutFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasMassachusettsMarylandMichiganMissouriNorth CarolinaNorth DakotaNebraskaNevadaNew York
Questions about this recall
Why was it recalled?
European version of microcatheter were distributed within US which contain a different "Indications for Use".
Which lots are affected?
UDI: 00763000311438/ Lot # B510757, B593510, B610689
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 93922This product is part of a recall event; the main page for the event is The Apollo Onyx Delivery Microcatheter recalled by Micro Therapeutics.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | The Apollo Onyx Delivery Microcatheter recalled by Micro Therapeutics | Micro Therapeutics | Other | Nationwide |
More recalls from Micro Therapeutics
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pipeline Flex Embolization Device with Shield Technology recalled | Micro Therapeutics | Labeling Errors | Nationwide |
| Device | CLASS II | Pipeline Flex Embolization Device with Shield Technology recalled | Micro Therapeutics | Labeling Errors | Nationwide |
| Device | CLASS I | Medtronic Pipeline Vantage Embolization Device recalled | Micro Therapeutics | Other | Nationwide |
| Device | CLASS I | Medtronic Pipeline Vantage Embolization Device recalled | Micro Therapeutics | Other | Nationwide |
| Device | CLASS II | The Apollo Onyx Delivery Microcatheter recalled by Micro Therapeutics | Micro Therapeutics | Other | Nationwide |
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| Device | CLASS II | Automated Impella Controller (AIC) recalled by Abiomed | Abiomed | Potency & Assay | Nationwide |
| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |