Use caution Medical device recall · FDA · Published December 8, 2020

Medtronic Ares Catheter Recall: Risk of Post-Op Infection from Seal Defect

Medtronic recalls specific Ares Antibiotic-Impregnated Catheters (REF 95001) due to potential seal defects that could compromise sterility and increase infection risk after hydrocephalus surgery.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0740-2021Medical device Medtronic ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmMedtronic Neurosurgery5290 California Ave · Irvine, CA 92617-3073

✎ GovInfoNow plain-language explainer

Medtronic is recalling certain Ares Antibiotic-Impregnated Catheters used in hydrocephalus treatment because a seal defect might allow contamination, raising the risk of post-surgery infections. This affects patients who have received these catheters as part of a shunt system. Read more at govinfonow.com/recall/63705-medtronic-ares-catheter-recall-risk-of-post-op-infection-from.

Source Summary by GovInfoNow · govinfonow.com/recall/63705-medtronic-ares-catheter-recall-risk-of-post-op-infection-from · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0740-2021

Cite this page

“Medtronic Ares Catheter Recall: Risk of Post-Op Infection from Seal Defect.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63705-medtronic-ares-catheter-recall-risk-of-post-op-infection-from. Based on FDA recall #Z-0740-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0740-2021%22&limit=1).

The FDA announced on 2020-12-08 that Medtronic Neurosurgery is recalling the Medtronic Ares Antibiotic-Impregnated Catheter due to a potential seal defect. This defect may compromise sterility and increase the risk of post-operative infection.

How to tell if you have it

Brand: Medtronic
Product: Medtronic Ares Antibiotic-Impregnated Catheter
REF: 95001
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
Quantity: 3,858 units

The hazard

According to the FDA, 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.

Context

GovInfoNow's records show Medtronic Neurosurgery has 9 other recalls on record since 2017-12-20. Other recent recalls of similar products include Medtronic Neurosurgery Ventriculostomy Kit Recall: Endotoxin Risk (2026-06-17), Becker External Drainage System: Cracks or Leaks in Stopcocks Risk (2024-11-01), and Medtronic Duet Drainage System Recall: Risk of Catheter Disconnection (2024-01-22). Other recent recalls of similar products include Stryker BARD EP XT Decapolar Steerable Catheter Recall: Incomplete Seals Risk Infection (2026-04-10), Stryker Medtronic Marinr Steerable Catheter Recall: Incomplete Sterile Seals (2026-04-10), and Stryker BARD EP XT Steerable Catheter Recall: Incomplete Sterile Seals (2026-04-10).

How to tell if you have this one

Check the lot number on the catheter packaging. The recalled items have specific lot numbers listed in the recall notice, including 0010038455 through 0010393228 and EB00006085 through EB00009476.

Brand
Medtronic
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
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

Recall number	Product, codes & lots	Quantity
Z-0738-2021	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.; Lot Numbers: 0010052549, 0010289829, 0010305920, 0010353501, 0010384893, 0010052552, 0010289830, 0010305921, 0010353502, 0010384894, 0010149011, 0010289831, 0010305923, 0010353503, 0010384895, 0010149013, 0010289833, 0010305926, 0010353504, 0010384896, 0010258434, 0010289834, 0010316955,, 0010369362, 0010393213, 0010265136, 0010297686, 0010316956, 0010369364, 0010393215, 0010265137, 0010297689, 0010316957, 0010369365, 0010393216, 0010265138, 0010297691, 0010316958, 0010376787, 0010393814, 0010278408, 0010297693, 0010336617, 0010376788, 0010393839, 0010278409, 0010297696, 0010336618, 0010376789, 0010289827, 0010305912, 0010336619, 0010376790, 0010289828, 0010305919, 0010353500, 0010384892	3,165 units
Z-0739-2021	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.; Lot numbers: 0010258435, 0010281390, 0010312360, 0010353505, 0010384900, 0010273889, 0010281391, 0010312361, 0010353507, 0010384901, 0010273890, 0010281392, 0010312362, 0010369366, 0010384903, 0010273891, 0010289835, 0010316959, 0010369367, 0010393220, 0010273893, 0010289836, 0010316960, 0010376784, 0010393221, 0010278418, 0010297678, 0010316961, 0010376785, 0010278427, 0010305929, 0010316963, 0010376786, 0010281384, 0010305937, 0010336620, 0010384897	1,926 units
Z-0740-2021	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.; 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	3,858 units

Based on the official FDA remedy

What to do — step by step

Check Lot Number
Look for the lot number on the catheter packaging to determine if it is in the recalled list.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 29 days after the firm started it.

Dec 8, 2020Firm started the recall
Dec 28, 2020FDA classified it Class II
Jan 6, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63705-medtronic-ares-catheter-recall-risk-of-post-op-infection-from">Medtronic Ares Catheter Recall: Risk of Post-Op Infection from Seal Defect (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0740-2021 (December 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0740-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.