Medtronic Neurosurgery: 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.

Recall number

Z-0740-2021

Recalling firm

Medtronic Neurosurgery

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.

Status

Open, Classified

Initiated

2020-12-08

Posted

not on file

Terminated

not on file

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.

Root cause

Packaging change control

Action

On 12/8/2020, Medtronic sent an "Urgent: Medical Device Recall" Notification via FedEx to affected consignees. In addition, to providing consignees information on the recall device, Medtronic ask consignees to take the following actions: 1. Identify, segregate, and quarantine affected products within your inventory. The list of affected lots is included. 2. Contact Medtronic to return affected product and receive replacement(s). See instructions on next page. 3. Please complete and return the customer confirmation form, even if you do not have any affected product 4. Adverse events or quality problems experienced with this product should be reported to Medtronic and to the FDA MedWatch Adverse Event Reporting program via: - E-mail Medtronic at RS.MNSProdExperienceHelp@Medtronic.com or call 1-877-526-5432. Online at the FDA website1 (form available to fax or mail) or call FDA at 1-800-FDA-1088.

Quantity

3,858 units

Distribution

Worldwide Distribution. US nationwide, Albania, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, Germany, Greece, Guam, Hong Kong, Hungary, India, Islamic Republic of Iran, Ireland, Israel, Italy, Latvia, Macao, Malaysia, Mauritius, Republic of Moldova, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam

Lot, serial or model codes

Lot Numbers: 0010038455, 0010258429, 0010289822, 0010316971, 0010376783, 0010061294, 0010258430, 0010289823, 0010316972, 0010384872, 0010061295, 0010258433, 0010297674, 0010316973, 0010384874, 0010083617, 0010265129, 0010297675, 0010336621, 0010384881, 0010083618, 0010265130, 0010297676, 0010336622, 0010384888, 0010083619, 0010265131, 0010297683, 0010336623, 0010393228, 0010083620, 0010265133, 0010305904, 0010353498, EB00006085, 0010083622, 0010265134, 0010305905, 0010353499, EB00006086, 0010083623, 0010265135, 0010305906, 0010369357, EB00006166, 0010097240, 0010278428, 0010305907, 0010369358, EB00007496, 0010097241, 0010278430, 0010305908, 0010369359, EB00007537, 0010097249, 0010281382, 0010305909, 0010376779, EB00009476, 0010097250, 0010281383, 0010316967, 0010376781, 0010097251, 0010289819, 0010316968, 0010376782

510(k) numbers

["K110560"]

PMA numbers

not on file

Product code

JXG

Firm FEI

3015531529

Firm city

Irvine

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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