Micro Therapeutics, Inc.: 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 cat

Hazard

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

Details from the source

Reason for recall: European version of microcatheter were distributed within US which contain a different "Indications for Use". 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. Quantity: 95 units Lot/code info: UDI: 00763000311445/ Lot # B510758, B555761, B615024, B615025, B629693, B629694

UPC codes

00763000311445

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.