Synchromed II programmable pump
Medical device recall Z-0508-2020. Published in FDA’s Enforcement Report on Dec 11, 2019.
- FDA Class I
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 Dec 11, 2019. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 10820 units 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), 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 potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a permanent motor stall.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
10820 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Number 8637-20 Serial Numbers: NGP000003H NGP000008H NGP000009H NGP000011H NGP000013H NGP000014H NGP000017H NGP000018H NGP000019H NGP000020H NGP000023H NGP000024H NGP000026H NGP000027H NGP000029H NGP000031H NGP000032H NGP000033H…
Every code shown here, 1,997 characters
Product Number 8637-20 Serial Numbers: NGP000003H NGP000008H NGP000009H NGP000011H NGP000013H NGP000014H NGP000017H NGP000018H NGP000019H NGP000020H NGP000023H NGP000024H NGP000026H NGP000027H NGP000029H NGP000031H NGP000032H NGP000033H NGP000034H NGP000035H NGP000036H NGP000037H NGP000038H NGP000039H NGP000040H NGP000046H NGP000048H NGP000071H NGP000076H NGP000086H NGP000106H NGP000107H NGP000111H NGP000119H NGP000128H NGP000138H NGP000142H NGP000143H NGP000145H NGP000150H NGP000159H NGP000160H NGP000163H NGP000176H NGP000178H NGP000184H NGP000197H NGP000198H NGP000199H NGP000204H NGP000242H NGP000245H NGP000249H NGP000251H NGP000252H NGP000253H NGP000254H NGP000255H NGP000256H NGP000257H NGP000258H NGP000261H NGP000269H NGP000270H NGP000274H NGP000276H NGP000278H NGP000281H NGP000282H NGP000290H NGP000293H NGP000295H NGP000296H NGP000299H NGP000300H NGP000303H NGP000304H NGP000308H NGP000311H NGP000313H NGP000317H NGP000324H NGP000325H NGP000329H NGP000330H NGP000334H NGP000337H NGP000339H NGP000340H NGP000343H NGP000351H NGP000352H NGP000353H NGP000360H NGP000362H NGP000363H NGP000366H NGP000367H NGP000374H NGP000375H NGP000376H NGP000377H NGP000382H NGP000386H NGP000390H NGP000397H NGP000399H NGP000419H NGP000427H NGP000445H NGP000456H NGP000468H NGP000469H NGP000477H NGP000482H NGP000487H NGP000489H NGP000491H NGP000494H NGP000495H NGP000498H NGP000500H NGP000503H NGP000507H NGP000512H NGP000514H NGP000516H NGP000517H NGP000518H NGP000519H NGP000524H NGP000527H NGP000529H NGP000531H NGP000534H NGP000536H NGP000539H NGP000545H NGP000546H NGP000547H NGP000548H NGP000550H NGP000552H NGP000560H NGP000562H NGP000563H NGP000564H NGP000565H NGP000568H NGP000579H NGP000580H NGP000585H NGP000601H NGP000602H NGP000603H NGP000604H NGP000605H NGP000606H NGP000607H NGP000609H NGP000610H NGP000611H NGP000612H NGP000613H NGP000614H NGP000615H NGP000616H NGP000618H NGP000619H NGP000621H NGP000622H NGP000623H NGP000624H NGP000625H NGP000626H NGP000627H NGP000628H NGP000630H…
FDA’s list runs to 127,210 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.
US and Canada, Asia -Pacific (APAC), China, Europe, Middle East and Africa (EMAE), Latin America (LATAM)
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Oct 11, 2019.
- FDA classified it on Dec 3, 2019.
- FDA’s Enforcement Report published it on Dec 11, 2019.
- FDA terminated it on Sep 15, 2023.
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 127,210 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.