Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported June 19, 2019
InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim neurostimulators for sacral neuromodulation therapy. The clinician uses the Clinician app to program settings for the patient. The A510 Clinician app, HH90 Handset, TM90 Communicator along with th
There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer).
Medtronic Neuromodulation recalled InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 P… - a moderate-severity action.
InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 P… was recalled by Medtronic Neuromodulation in June 19, 2019. Reason: There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clin…. Check the official notice for the remedy. Verify recall #Z-1774-2019 with the FDA Devices before acting.
The recall
Medtronic Neuromodulation issued this moderate-severity FDA Devices recall-There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clin….
- Moderate
- severity level
- 14K units
- affected scope
- Class II
- classification
- June 19, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1774-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1774-2019) was formally reported on June 19, 2019, with the manufacturer initiating the action on May 15, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medtronic Neuromodulation is listed as the recalling firm, operating out of Minneapolis, MN. Federal records list the affected scope as 13979 units.
The documented reason for this recall is: There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer). Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide & PR, and Germany, Switzerland, Italy, Spain, France, UK, Norway, Denmark, Finland, Netherlands. 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, 6 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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
13979 units
Related Recalls
6
6 from same agency
Product description
InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim neurostimulators for sacral neuromodulation therapy. The clinician uses the Clinician app to program settings for the patient. The A510 Clinician app, HH90 Handset, TM90 Communicator along with the A520 Patient app are only sold as a kit (TH90).
Reason for recall
There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1774-2019 |
| Date reported | June 19, 2019 |
| Date initiated | May 15, 2019 |
| Recalling firm | Medtronic Neuromodulation |
| Firm location | Minneapolis, MN |
| Affected scope | 13979 units |
| Distribution | Worldwide Distribution - US Nationwide & PR, and Germany, Switzerland, Italy, Spain, France, UK, Norway, Denmark, Finland, Netherlands |
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-1774-2019) 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? ▼
InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim neurostimulators for sacral neuromodulation therapy. The clinician uses the Clinician app to program settings for the patient. The A510 Clinician app, HH90 Handset, TM90 Communicator along with the A520 Patient app are only sold as a kit (TH90).. Recalled by Medtronic Neuromodulation. Units affected: 13979 units.
Why was this product recalled? ▼
There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 19, 2019. Severity: Moderate. Recall number: Z-1774-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide & PR, and Germany, Switzerland, Italy, Spain, France, UK, Norway, Denmark, Finland, Netherlands.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1774-2019) 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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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 June 19, 2019. 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 August 2026.