SynchroMed II
Medical device recall Z-0774-2025. 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
- 3981 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 CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
3981 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN: 00763000447090 00763000729141 00763000737290 00763000447090; Serial Numbers: NPL3020725 NPL3021958 NPL3021963 NPL3021966 NPL3021969 NPL3021970 NPL3021971 NPL3021974 NPL3021983 NPL3021984 NPL3021990 NPL3021997 NPL3022002 NPL3022005…
Every code shown here, 1,997 characters
GTIN: 00763000447090 00763000729141 00763000737290 00763000447090; Serial Numbers: NPL3020725 NPL3021958 NPL3021963 NPL3021966 NPL3021969 NPL3021970 NPL3021971 NPL3021974 NPL3021983 NPL3021984 NPL3021990 NPL3021997 NPL3022002 NPL3022005 NPL3022014 NPL3022022 NPL3022031 NPL3022032 NPL3022038 NPL3022044 NPL3022052 NPL3022062 NPL3022069 NPL3022070 NPL3022071 NPL3022072 NPL3022073 NPL3022074 NPL3022109 NPL3022114 NPL3022118 NPL3022124 NPL3022125 NPL3022131 NPL3022139 NPL3022187 NPL3022190 NPL3022193 NPL3022194 NPL3022195 NPL3022212 NPL3022213 NPL3022216 NPL3022218 NPL3022245 NPL3022257 NPL3022278 NPL3022280 NPL3022289 NPL3022291 NPL3022304 NPL3022311 NPL3022313 NPL3022314 NPL3022328 NPL3022352 NPL3022357 NPL3022364 NPL3022365 NPL3022711 NPL3022713 NPL3022714 NPL3022715 NPL3022717 NPL3022735 NPL3022761 NPL3022762 NPL3022765 NPL3022767 NPL3022768 NPL3022769 NPL3022776 NPL3022791 NPL3022793 NPL3022795 NPL3022810 NPL3022811 NPL3022815 NPL3022817 NPL3022818 NPL3022831 NPL3022836 NPL3022838 NPL3022841 NPL3022844 NPL3022856 NPL3022858 NPL3022869 NPL3022870 NPL3022873 NPL3022874 NPL3022876 NPL3022877 NPL3022879 NPL3022893 NPL3022899 NPL3022900 NPL3022912 NPL3022918 NPL3022922 NPL3022926 NPL3022939 NPL3022940 NPL3022942 NPL3022954 NPL3022957 NPL3022958 NPL3022959 NPL3022968 NPL3022969 NPL3022973 NPL3022974 NPL3022981 NPL3022999 NPL3023030 NPL3023032 NPL3023035 NPL3023038 NPL3023042 NPL3023043 NPL3023048 NPL3023050 NPL3023054 NPL3023059 NPL3023061 NPL3023065 NPL3023067 NPL3023076 NPL3023078 NPL3023086 NPL3023093 NPL3023097 NPL3023123 NPL3023131 NPL3023132 NPL3023133 NPL3023136 NPL3023146 NPL3023148 NPL3023149 NPL3023150 NPL3023153 NPL3023156 NPL3023167 NPL3023175 NPL3023180 NPL3023192 NPL3023194 NPL3023197 NPL3023205 NPL3023218 NPL3023229 NPL3023237 NPL3023239 NPL3023241 NPL3023242 NPL3023245 NPL3023254 NPL3023256 NPL3023257 NPL3023260 NPL3023262 NPL3023268 NPL3023272 NPL3023278 NPL3023288 NPL3023292 NPL3023315 NPL3023317 NPL3023319 NPL3023322 NPL3023323 NPL3023330 NPL3023331…
FDA’s list runs to 43,874 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 43,874 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.