Agency classClass IIOur severity:High FDA (Devices)·Z-0738-2021·Announced 2021-01-06

Medtronic Ares Antibiotic-Impregnated Catheter Recall for Seal Defect

Medtronic is recalling Ares Antibiotic-Impregnated Catheters due to a potential seal defect that may compromise sterility and increase the risk of post-operative infection.

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 involves a risk-of-harm product (potential post-operative infection) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Medtronic Neurosurgery is recalling the Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101. This sterile, prescription-only device is 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 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 units were distributed worldwide, including nationwide in the United States and in numerous other countries. The recall covers 3,165 units across specific lot numbers. Healthcare providers and patients should contact Medtronic Neurosurgery for further instructions on how to proceed with the recall.

The recalled product

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.
Manufacturer: Medtronic Neurosurgery
Category: Medical Device — Neurosurgery
Hazard: infection
sterility-compromise
Affected units: 3,165

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: 0010052549
0010289829
0010305920
0010353501
0010384893
0010052552
0010289830
0010305921
0010353502
0010384894
0010149011
0010289831
0010305923
0010353503
0010384895
0010149013
0010289833
0010305926
0010353504
0010384896

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

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Same hazard · infection