The Recall Desk
HighFDA (Devices)·Z-0740-2021·Announced 2021-01-06

Medtronic Ares Antibiotic-Impregnated Catheter Recalled for Seal Defect

Medtronic is recalling 3,858 Ares Antibiotic-Impregnated Catheters due to a potential seal defect that may compromise sterility and increase infection risk.

What this means for you

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 (sterility compromise leading to infection) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Medtronic Neurosurgery is recalling 3,858 units of the Ares Antibiotic-Impregnated Catheter (REF: 95001). This sterile, prescription-only medical device is used in the treatment of hydrocephalus as a component of a shunt system for draining or shunting cerebrospinal fluid.

The recall is issued because there is 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. Healthcare providers and patients should contact Medtronic Neurosurgery for further instructions regarding the recall and potential replacement or removal of the devices.

The recalled product

Product
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, 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 Shunt
Hazard
Affected units
3,858

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: 0010038455
  • 0010258429
  • 0010289822
  • 0010316971
  • 0010376783
  • 0010061294
  • 0010258430
  • 0010289823
  • 0010316972
  • 0010384872
  • 0010061295
  • 0010258433
  • 0010297674
  • 0010316973
  • 0010384874
  • 0010083617
  • 0010265129
  • 0010297675
  • 0010336621
  • 0010384881

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 →

Related recalls

Same manufacturer · Medtronic Neurosurgery

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Same hazard · infection

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