Agency classClass IIOur severity:High FDA (Devices)·Z-0739-2021·Announced 2021-01-06

Medtronic Ares Antibiotic-Impregnated Catheter Recalled for Seal Defect

Medtronic is recalling 1,926 Ares Antibiotic-Impregnated Catheters due to a potential seal defect that may compromise sterility and increase infection risk.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of post-operative infection from a compromised sterile barrier, which fits the criteria for high-risk products where injury has not yet been reported.

Plain-English summary

Medtronic Neurosurgery is recalling 1,926 units of the Medtronic Ares Antibiotic-Impregnated Catheter (REF: 93092). The recall is due to a potential defect on the seal of the outer pouch of the catheters. This defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection requiring further medical intervention.

The affected catheters are sterile, prescription-only devices used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated. The recall covers specific lot numbers distributed worldwide, including the United States and numerous international locations.

Healthcare providers and patients should check their inventory and patient records for the affected lot numbers. If the device is in use, contact Medtronic Neurosurgery for instructions on removal or replacement. Do not use the recalled catheters for new procedures.

The recalled product

Product: Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, 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.
Manufacturer: Medtronic Neurosurgery
Category: Medical Device — Neurosurgical Catheter
Hazard: infection
sterility-compromise
Affected units: 1,926

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot numbers: 0010258435
0010281390
0010312360
0010353505
0010384900
0010273889
0010281391
0010312361
0010353507
0010384901
0010273890
0010281392
0010312362
0010369366
0010384903
0010273891
0010289835
0010316959
0010369367
0010393220

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Medtronic Neurosurgery under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Medtronic Neurosurgery

See all →

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Same hazard · infection