Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 8, 2017
Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve is a shunt component designed to allow for continuous flow of cerebrospinal fluid (CSF) from the ventricles of the brain to the peritoneal cavity or right atrium of the heart. mechanism. Strata Valve Magnet Reverse Polarity (Excludes StrataMR). Catalog No. 27739 27740 27786 27787
Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies between the pressur…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Neurosurgery recalled Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All C… - a moderate-severity action.
Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All C… was recalled by Medtronic Neurosurgery in February 8, 2017. Reason: Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2…. Check the official notice for the remedy. Verify recall #Z-1121-2017 with the FDA Devices before acting.
The recall
Medtronic Neurosurgery issued this moderate-severity FDA Devices recall-Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2….
- Moderate
- severity level
- 316K units
- affected scope
- Class II
- classification
- February 8, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1121-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1121-2017) was formally reported on February 8, 2017, with the manufacturer initiating the action on January 17, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Neurosurgery is listed as the recalling firm, operating out of Goleta, CA. Federal records list the affected scope as 315,997, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies between the pressure/performance level (PL) at which the va… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Algeria India Poland Armenia Indonesia Portugal Australia Iran Austria Iraq Qatar Bangladesh Ireland Republic of …. 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
315,997
Related Recalls
6
3 from same agency
Product description
Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve is a shunt component designed to allow for continuous flow of cerebrospinal fluid (CSF) from the ventricles of the brain to the peritoneal cavity or right atrium of the heart. mechanism. Strata Valve Magnet Reverse Polarity (Excludes StrataMR). Catalog No. 27739 27740 27786 27787 27788 27789 27794 27812 27814 27815 27816 27817 27818 27820 27821 27822 27823 27824 27825 27827 27828 27830 27831 27832 27848 27864 27867 27868 27888 27903 27922 27823 27924 23042 27925 27926 27927 27932 27933 42335 42355 42365 42836 42856 42866 44420 44421 44430 44465 46070 46075 46080 46085 46635 46655 46665 46836 46856 46866 46871 46876 46881 46886 92355 92365 92856 92866 96655 96665
Reason for recall
Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies between the pressure/performance level (PL) at which the valve was set and the readings determined via an x-ray image.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1121-2017 |
| Date reported | February 8, 2017 |
| Date initiated | January 17, 2017 |
| Recalling firm | Medtronic Neurosurgery |
| Firm location | Goleta, CA |
| Affected scope | 315,997 |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Algeria India Poland Armenia Indonesia Portugal Australia Iran Austria Iraq Qatar Bangladesh Ireland Republic of Montenegro Barbados… |
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-1121-2017) 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 Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve is a shunt component designed to allow for continuous flow of cerebrospinal fluid (CSF) from the ventricles of the brain to the peritoneal cavity or right atrium of the heart. mechanism. Strata Valve Magnet Reverse Polarity (Excludes StrataMR). Catalog No. 27739 27740 27786 27787 27788 27789 27794 27812 27814 27815 27816 27817 27818 27820 27821 27822 27823 27824 27825 27827 27828 27830 27831 27832 27848 27864 27867 27868 27888 27903 27922 27823 27924 23042 27925 27926 27927 27932 27933 42335 42355 42365 42836 42856 42866 44420 44421 44430 44465 46070 46075 46080 46085 46635 46655 46665 46836 46856 46866 46871 46876 46881 46886 92355 92365 92856 92866 96655 96665. Recalled by Medtronic Neurosurgery. Units affected: 315,997.
Why was this product recalled? ▼
Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies between the pressure/performance level (PL) at which the valve was set and the readings determined via an x-ray image.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 8, 2017. Severity: Moderate. Recall number: Z-1121-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Algeria India Poland Armenia Indonesia Portugal Australia Iran Austria Iraq Qatar Bangladesh Ireland Republic of Montenegro Barbados Israel Republic of Serbia Belarus Italy Romania Belgium Jamaica Russian Federation Bosnia and Herzegovina Japan Saudi Arabia Botswana Jordan Singapore Bulgaria Kazakhstan Slovakia Cambodia Kenya South Africa Canada Kuwait South Korea Canary Islands Latvia Spain Cayman Islands Lebanon Sri Lanka China Libya Sweden Croatia Lithuania Switzerland Cyprus Macau Syria.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1121-2017) 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 February 8, 2017. 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.