Z-2471-2012Class II

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

Name: Z-2471-2012 UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065
Creator: Micro Therapeutics Inc, Dba Ev3 Neurovascular
Published: 2011-09-23
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2011-09-23 / Terminated / root cause: labeling and UDI

FDA source

Micro Therapeutics Inc, Dba Ev3 Neurovascular began a recall of UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral... on 2011-09-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2471-2012
Classification: Class II
Status: Terminated
Initiated: 2011-09-23
Posted: 2012-09-27
Terminated: 2012-09-28
Recalling firm: Medtronic, Inc.
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.
Product code: KRA Catheter, Continuous Flush
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Micro Therapeutics Inc, Dba Ev3 Neurovascular sent a recall notification letter dated September 23, 2011 to all their affected customers. The letter identified the affected product, problem, and actions to be taken. The notification letter also provides the customer (physician) with appropriate information regarding the affected products. The letter instructs customer to stop using the affected product, segregate from inventory and return for replacement with conforming product. The notice requests the customer to complete and return the reply form indicating use or return of devices in the affected lot(s). Customers with questions regarding the recall letter were instructed to contact Kim Salceda at (949) 680-1305.
Quantity in commerce: 36 units
Distribution: Worldwide Distribution - US Nationwide including the states: MN, FL, OR, TX and the countries of: Brazil, Belgium, Czech Republic, Finlind, France, Germany, Netherlands, Poland, and United Kingdom.
Product codes and lots: Lot # 9374298

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2471-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2471-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-27
Z-2472-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-27

Product code KRA

K024118Class IIUltraflow Hpc Flow Directed Micro Catheter, Models 105-5065 and 105-5066Micro Therapeutics, Inc. / cleared 2003-02-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)