RecallRadar

FDA Device recall Z-2471-2012

UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065

On 2012-10-03 the FDA classified a Class II recall of UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065 by Micro Therapeutics, citing the recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been misla….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2471-2012
ClassificationClass II
Statusterminated
Initiated2011-09-23
Published2012-10-03
Last updated2026-09-13 11:53 UTC
CompanyMicro Therapeutics
DistributionUS

Product

UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.

Reason

The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.

Identifiers

code_infoLot # 9374298

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2471-2012%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.