Recall Z-0738-2021— Medtronic Neurosurgery

Name: FDA recall Z-0738-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-08

Class II · Ongoing

Class II FDA medical device recall by Medtronic Neurosurgery, initiated 2020-12-08. It names one FDA 510(k) clearance: K110560. Product: Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.. Reason: There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention..

Recalling firm: Medtronic Neurosurgery
Classification: Class II
Status: Ongoing
Initiated: 2020-12-08
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K110560 — MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETERMedtronic Neurosurgery·cleared 2011-11-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

Reason for recall

There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.

Data sourced from openFDA. This site is unofficial and independent of the FDA.