Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported January 6, 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.
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-o…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Neurosurgery recalled Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in th… - a moderate-severity action.
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in th… was recalled by Medtronic Neurosurgery in January 6, 2021. Reason: There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the …. Check the official notice for the remedy. Verify recall #Z-0740-2021 with the FDA Devices before acting.
The recall
Medtronic Neurosurgery issued this moderate-severity FDA Devices recall-There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the ….
- Moderate
- severity level
- 4K units
- affected scope
- Class II
- classification
- January 6, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0740-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0740-2021) was formally reported on January 6, 2021, with the manufacturer initiating the action on December 8, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medtronic Neurosurgery is listed as the recalling firm, operating out of Irvine, CA. Federal records list the affected scope as 3,858 units.
The documented reason for this recall is: 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 me… Distribution data in the federal record shows the product reached: 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…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3,858 units
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0740-2021 |
| Date reported | January 6, 2021 |
| Date initiated | December 8, 2020 |
| Recalling firm | Medtronic Neurosurgery |
| Firm location | Irvine, CA |
| Affected scope | 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, G… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0740-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtronic Neurosurgery. Units affected: 3,858 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 6, 2021. Severity: Moderate. Recall number: Z-0740-2021.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0740-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 6, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.