SynchroMed II
Medical device recall Z-0773-2025. 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
- 566 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 CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D
566 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN: 00763000094027 00763000077730 00763000421007 00763000447090; Serial Numbers: NPL3000006 NPL3000007 NPL3000009 NPL3000011 NPL3000016 NPL3000017 NPL3000023 NPL3000026 NPL3000029 NPL3000043 NPL3000046 NPL3000050 NPL3000055 NPL3000063…
Every code shown here, 1,997 characters
GTIN: 00763000094027 00763000077730 00763000421007 00763000447090; Serial Numbers: NPL3000006 NPL3000007 NPL3000009 NPL3000011 NPL3000016 NPL3000017 NPL3000023 NPL3000026 NPL3000029 NPL3000043 NPL3000046 NPL3000050 NPL3000055 NPL3000063 NPL3000068 NPL3000083 NPL3000090 NPL3000103 NPL3000105 NPL3000129 NPL3000185 NPL3000186 NPL3000187 NPL3000189 NPL3000191 NPL3000192 NPL3000197 NPL3000198 NPL3000203 NPL3000205 NPL3000206 NPL3000209 NPL3000210 NPL3000215 NPL3000216 NPL3000219 NPL3000222 NPL3000223 NPL3000229 NPL3000232 NPL3000237 NPL3000240 NPL3000242 NPL3000246 NPL3000248 NPL3000250 NPL3000252 NPL3000253 NPL3000255 NPL3000262 NPL3000264 NPL3002259 NPL3002261 NPL3002266 NPL3002273 NPL3002274 NPL3002275 NPL3002278 NPL3002283 NPL3002288 NPL3002296 NPL3002306 NPL3002655 NPL3002660 NPL3002661 NPL3002666 NPL3002667 NPL3002669 NPL3002670 NPL3002672 NPL3002679 NPL3002685 NPL3002686 NPL3002687 NPL3002693 NPL3002694 NPL3002699 NPL3002700 NPL3002702 NPL3002703 NPL3002704 NPL3002705 NPL3002706 NPL3002707 NPL3002710 NPL3002716 NPL3002717 NPL3002718 NPL3002719 NPL3002723 NPL3002727 NPL3002732 NPL3002734 NPL3002735 NPL3002736 NPL3002737 NPL3002738 NPL3002739 NPL3002741 NPL3002745 NPL3002747 NPL3002752 NPL3002756 NPL3002757 NPL3002872 NPL3002874 NPL3002875 NPL3002878 NPL3002879 NPL3002880 NPL3002881 NPL3002885 NPL3002891 NPL3002892 NPL3002898 NPL3002899 NPL3002902 NPL3002906 NPL3002907 NPL3002908 NPL3002909 NPL3002910 NPL3002911 NPL3002914 NPL3002915 NPL3002918 NPL3002922 NPL3002924 NPL3002925 NPL3002927 NPL3002940 NPL3002942 NPL3002949 NPL3002950 NPL3002961 NPL3003300 NPL3003310 NPL3003311 NPL3003313 NPL3003315 NPL3003317 NPL3003325 NPL3003337 NPL3003339 NPL3003355 NPL3003359 NPL3003513 NPL3003558 NPL3003560 NPL3003570 NPL3003694 NPL3003696 NPL3003700 NPL3003705 NPL3003720 NPL3003725 NPL3003735 NPL3003737 NPL3003987 NPL3004860 NPL3004870 NPL3004879 NPL3004880 NPL3004914 NPL3004942 NPL3004951 NPL3004960 NPL3004992 NPL3005006 NPL3005009 NPL3005018 NPL3005769 NPL3005790 NPL3005843…
FDA’s list runs to 6,308 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 6,308 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.