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Recall Observatory FDA recall evidence

Device product

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.

Z-1253-2024

January 11, 2024

Class II

Product summary

Firm
Micro Therapeutics, Inc.
Event
Event 93922
Status
Ongoing
Classification
Class II
Quantity
95 units
Official record key
device-enforcement:Z-1253-2024

Official wording

Reason: European version of microcatheter were distributed within US which contain a different "Indications for Use".

Code information: UDI: 00763000311445/ Lot # B510758, B555761, B615024, B615025, B629693, B629694

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    European version of microcatheter were distributed within US which contain a different "Indications for Use".