Stimulation RC Clinician Programmer Application
Medical device recall Z-1543-2025. Published in FDA’s Enforcement Report on Apr 16, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 16, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1493 devices how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
1493 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 00763000371463; Serial Numbers: NPL1000037 NPL1000042 NPL1000053 NPL1000055 NPL1000056 NPL1000062 NPL1000067 NPL1000069 NPL1000072 NPL1000073 NPL1000074 NPL1000075 NPL1000076 NPL1000098 NPL1000135 NPL1000137 NPL1000138 NPL1000151…
Every code shown here, 1,998 characters
UDI-DI: 00763000371463; Serial Numbers: NPL1000037 NPL1000042 NPL1000053 NPL1000055 NPL1000056 NPL1000062 NPL1000067 NPL1000069 NPL1000072 NPL1000073 NPL1000074 NPL1000075 NPL1000076 NPL1000098 NPL1000135 NPL1000137 NPL1000138 NPL1000151 NPL1000160 NPL1000161 NPL1000165 NPL1000173 NPL1000174 NPL1000175 NPL1000179 NPL1000180 NPL1000185 NPL1000186 NPL1000188 NPL1000189 NPL1000191 NPL1000195 NPL1000230 NPL1000238 NPL1000242 NPL1000244 NPL1000245 NPL1000246 NPL1000248 NPL1000249 NPL1000252 NPL1000281 NPL1000292 NPL1000295 NPL1000297 NPL1000301 NPL1000303 NPL1000304 NPL1000305 NPL1000323 NPL1000325 NPL1000331 NPL1000344 NPL1000361 NPL1000363 NPL1000364 NPL1000365 NPL1000370 NPL1000429 NPL1000435 NPL1000443 NPL1000446 NPL1000447 NPL1000453 NPL1000486 NPL1000502 NPL1000504 NPL1000505 NPL1000506 NPL1000507 NPL1000509 NPL1000510 NPL1000514 NPL1000516 NPL1000518 NPL1000519 NPL1000528 NPL1000533 NPL1000555 NPL1000558 NPL1000561 NPL1000562 NPL1000575 NPL1000584 NPL1000585 NPL1000592 NPL1000603 NPL1000606 NPL1000612 NPL1000631 NPL1000634 NPL1000638 NPL1000639 NPL1000652 NPL1000653 NPL1000657 NPL1000776 NPL1000794 NPL1000814 NPL1000815 NPL1000817 NPL1000819 NPL1000834 NPL1000835 NPL1001212 NPL1001236 NPL1001241 NPL1001245 NPL1001246 NPL1001265 NPL1001273 NPL1001282 NPL1001301 NPL1001332 NPL1001339 NPL1001353 NPL1001354 NPL1001364 NPL1001369 NPL1001371 NPL1001389 NPL1001429 NPL1001434 NPL1001435 NPL1001436 NPL1001449 NPL1001464 NPL1001506 NPL1001507 NPL1001512 NPL1001520 NPL1001542 NPL1001549 NPL1001558 NPL1001588 NPL1001591 NPL1001592 NPL1001608 NPL1001647 NPL1001650 NPL1001670 NPL1001678 NPL1001694 NPL1001695 NPL1001697 NPL1001700 NPL1001702 NPL1001705 NPL1001707 NPL1001708 NPL1001709 NPL1001710 NPL1001711 NPL1001716 NPL1001717 NPL1001727 NPL1001728 NPL1001756 NPL1001759 NPL1001763 NPL1001764 NPL1001765 NPL1001769 NPL1001773 NPL1001789 NPL1001797 NPL1001798 NPL1001800 NPL1001801 NPL1001804 NPL1001811 NPL1001812 NPL1001815 NPL1001816 NPL1001817 NPL1001823 NPL1001824 NPL1001825…
FDA’s list runs to 16,462 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Austria, Belgium, Bulgaria, Canary Islands, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland, Portugal, Puerto Rico, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 4, 2025.
- FDA classified it on Apr 8, 2025.
- FDA’s Enforcement Report published it on Apr 16, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Neuromodulation, of Minneapolis, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 16,462 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.