VNS Therapy Program GMDN: 44077
Medical device recall Z-0663-2020. Published in FDA’s Enforcement Report on Dec 18, 2019.
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 18, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 47 states named in where it went
- 643 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 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?
This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices, if the output current is greater than 0.5mA. This can result in false high impedance values during patient follow-up.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
643 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number / UDI# GWQ57F2 01054250257504811118060521GWQ57F29910-0011-0500 72S77F2 0105425025750481111806052172S77F29910-0011-0500 1ZFTKJ2 010542502575048111180604211ZFTKJ29910-0011-0500 BRQ57F2…
Every code shown here, 1,989 characters
Serial Number / UDI# GWQ57F2 01054250257504811118060521GWQ57F29910-0011-0500 72S77F2 0105425025750481111806052172S77F29910-0011-0500 1ZFTKJ2 010542502575048111180604211ZFTKJ29910-0011-0500 BRQ57F2 01054250257504811118053121BRQ57F29910-0011-0500 9CP57F2 010542502575048111180529219CP57F29910-0011-0500 HCR77F2 01054250257504811118050421HCR77F29910-0011-0500 H5P57F2 01054250257504811118050321H5P57F29910-0011-0500 19S77F2 0105425025750481111804172119S77F29910-0011-0500 3YFTKJ2 010542502575048111180405213YFTKJ29910-0011-0500 68Q57F2 0105425025750481111803302168Q57F29910-0011-0500 H4S77F2 01054250257504811118031521H4S77F29910-0011-0500 C7KRPJ2 01054250257504811118031521C7KRPJ29910-0011-0500 8WQ77F2 010542502575048111180315218WQ77F29910-0011-0500 1VQ77F2 010542502575048111180315211VQ77F29910-0011-0500 1LJRPJ2 010542502575048111180315211LJRPJ29910-0011-0500 JFJRPJ2 01054250257504811118031421JFJRPJ29910-0011-0500 HVP57F2 01054250257504811118031421HVP57F29910-0011-0500 CBJRPJ2 01054250257504811118031421CBJRPJ29910-0011-0500 9HJRPJ2 010542502575048111180314219HJRPJ29910-0011-0500 1LQ57F2 010542502575048111180313211LQ57F29910-0011-0500 B6S77F2 01054250257504811118030921B6S77F29910-0011-0500 5NT77F2 010542502575048111180309215NT77F29910-0011-0500 75P57F2 0105425025750481111803052175P57F29910-0011-0500 32S77F2 0105425025750481111803052132S77F29910-0011-0500 6P7G1F2 010542502575048111180302216P7G1F29910-0011-0500 1J0C7F2 010542502575048111180228211J0C7F29910-0011-0500 J4R57F2 01054250257504811118022721J4R57F29910-0011-0500 61R77F2 0105425025750481111802272161R77F29910-0011-0500 1C0C7F2 010542502575048111180227211C0C7F29910-0011-0500 1LYB7F2 010542502575048111180226211LYB7F29910-0011-0500 DPS77F2 01054250257504811118021521dps77f29910-0011-0500 9LQ57F2 010542502575048111180215219lq57f29910-0011-0500 HDR77F2 01054250257504811118021421HDR77F29910-0011-0500 B5S77F2 01054250257504811118021421B5S77F29910-0011-0500 HCJRPJ2 01054250257504811118020721HCJRPJ29910-0011-0500 CCT77F2…
FDA’s list runs to 39,386 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.
IL, AK, AL, AR, AZ, CA, CA , CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD MI, MN, MO, MS, MT, NC, ND, NE, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WA , WI, WV, WY,
The states and territories these words name
47 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
- Wyoming
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 16, 2018.
- FDA classified it on Dec 10, 2019.
- FDA’s Enforcement Report published it on Dec 18, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- LivaNova USA Inc, of Houston, TX.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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 39,386 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.