SynchroMed II
Medical device recall Z-0771-2025. Published in FDA’s Enforcement Report on Jan 8, 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 Jan 8, 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
- 319 systems 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?
Software issues were identified in application version 2.x.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B
319 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN: 00643169890947, 00763000447090; Serial Numbers: NPL1000037 NPL1000042 NPL1000045 NPL1000048 NPL1000051 NPL1000054 NPL1000055 NPL1000056 NPL1000062 NPL1000069 NPL1000072 NPL1000073 NPL1000074 NPL1000075 NPL1000078 NPL1000083…
Every code shown here, 1,990 characters
GTIN: 00643169890947, 00763000447090; Serial Numbers: NPL1000037 NPL1000042 NPL1000045 NPL1000048 NPL1000051 NPL1000054 NPL1000055 NPL1000056 NPL1000062 NPL1000069 NPL1000072 NPL1000073 NPL1000074 NPL1000075 NPL1000078 NPL1000083 NPL1000092 NPL1000093 NPL1000094 NPL1000096 NPL1000098 NPL1000132 NPL1000151 NPL1000159 NPL1000161 NPL1000165 NPL1000166 NPL1000173 NPL1000174 NPL1000179 NPL1000180 NPL1000185 NPL1000186 NPL1000189 NPL1000191 NPL1000195 NPL1000196 NPL1000230 NPL1000233 NPL1000238 NPL1000239 NPL1000249 NPL1000257 NPL1000281 NPL1000297 NPL1000301 NPL1000303 NPL1000321 NPL1000323 NPL1000325 NPL1000331 NPL1000334 NPL1000343 NPL1000344 NPL1000361 NPL1000363 NPL1000367 NPL1000370 NPL1000486 NPL1000501 NPL1000504 NPL1000505 NPL1000506 NPL1000507 NPL1000509 NPL1000510 NPL1000515 NPL1000516 NPL1000518 NPL1000519 NPL1000528 NPL1000555 NPL1000556 NPL1000558 NPL1000561 NPL1000562 NPL1000563 NPL1000571 NPL1000573 NPL1000574 NPL1000584 NPL1000585 NPL1000592 NPL1000603 NPL1000606 NPL1000612 NPL1000627 NPL1000630 NPL1000631 NPL1000632 NPL1000634 NPL1000638 NPL1000639 NPL1001196 NPL1001209 NPL1001212 NPL1001214 NPL1001216 NPL1001228 NPL1001235 NPL1001236 NPL1001237 NPL1001241 NPL1001243 NPL1001245 NPL1001247 NPL1001249 NPL1001252 NPL1001259 NPL1001260 NPL1001265 NPL1001273 NPL1001277 NPL1001292 NPL1001293 NPL1001294 NPL1001296 NPL1001297 NPL1001298 NPL1001301 NPL1001304 NPL1001314 NPL1001323 NPL1001324 NPL1001325 NPL1001328 NPL1001330 NPL1001332 NPL1001333 NPL1001336 NPL1001337 NPL1001345 NPL1001353 NPL1001360 NPL1001361 NPL1001362 NPL1001363 NPL1001364 NPL1001366 NPL1001371 NPL1001374 NPL1001381 NPL1001387 NPL1001389 NPL1001398 NPL1001402 NPL1001407 NPL1001419 NPL1001431 NPL1001435 NPL1001436 NPL1001445 NPL1001461 NPL1001465 NPL1001500 NPL1001511 NPL1001514 NPL1001520 NPL1001524 NPL1001526 NPL1001527 NPL1001531 NPL1001532 NPL1001537 NPL1001539 NPL1001542 NPL1001543 NPL1001544 NPL1001545 NPL1001547 NPL1001697 NPL1001701 NPL1001702 NPL1001705 NPL1001709 NPL1001717…
FDA’s list runs to 3,562 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 - US Nationwide distribution.
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 Nov 21, 2024.
- FDA classified it on Dec 27, 2024.
- FDA’s Enforcement Report published it on Jan 8, 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 3,562 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.