VNS Therapy¿ AspireSR¿ Generator
Medical device recall Z-0462-2021. Published in FDA’s Enforcement Report on Nov 25, 2020.
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 Nov 25, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 29 states named in where it went
- 134 generators 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?
Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
VNS Therapy¿ AspireSR¿ Generator
134 generators, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number: 106 Serial Number UDI 1267031 010542502575006111191206172111182112670319910-0011-2101 1267050 010542502575006111191206172111182112670509910-0011-2101 1267039 010542502575006111191206172111182112670399910-0011-2101 1267030…
Every code shown here, 1,964 characters
Model Number: 106 Serial Number UDI 1267031 010542502575006111191206172111182112670319910-0011-2101 1267050 010542502575006111191206172111182112670509910-0011-2101 1267039 010542502575006111191206172111182112670399910-0011-2101 1267030 010542502575006111191206172111182112670309910-0011-2101 1267025 010542502575006111191206172111182112670259910-0011-2101 1267028 010542502575006111191206172111182112670289910-0011-2101 1267047 010542502575006111191206172111182112670479910-0011-2101 1267020 010542502575006111191206172111182112670209910-0011-2101 1267003 010542502575006111191206172111182112670039910-0011-2101 1267049 010542502575006111191206172111182112670499910-0011-2101 1267037 010542502575006111191206172111182112670379910-0011-2101 1267033 010542502575006111191206172111182112670339910-0011-2101 1267027 010542502575006111191206172111182112670279910-0011-2101 1267001 010542502575006111191206172111182112670019910-0011-2101 1267054 010542502575006111191206172111182112670549910-0011-2101 1267029 010542502575006111191206172111182112670299910-0011-2101 1267044 010542502575006111191209172111192112670449910-0011-2101 1267060 010542502575006111191209172111192112670609910-0011-2101 1267056 010542502575006111191209172111192112670569910-0011-2101 1267040 010542502575006111191209172111192112670409910-0011-2101 1267055 010542502575006111191209172111192112670559910-0011-2101 1267045 010542502575006111191209172111192112670459910-0011-2101 1267096 010542502575006111191209172111192112670969910-0011-2101 1267057 010542502575006111191209172111192112670579910-0011-2101 1267189 010542502575006111191210172111192112671899910-0011-2101 1267140 010542502575006111191210172111192112671409910-0011-2101 1267164 010542502575006111191210172111192112671649910-0011-2101 1267139 010542502575006111191210172111192112671399910-0011-2101 1267143 010542502575006111191210172111192112671439910-0011-2101 1267163 010542502575006111191210172111192112671639910-0011-2101 1267152…
FDA’s list runs to 8,612 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.
U.S.: AK, AL, AZ, CA, CO, DC, FL, HI, ID, IL, IN, KS, KY, LA, ME, MI, MN, MO, MT, NC, NE, NV, OK, OR, PR, TX, UT, VA, and WA O.U.S.: Argentina, Finland and Peru
The states and territories these words name
29 states and territories.
Every one of them
- Alaska
- Alabama
- Arizona
- California
- Colorado
- District of Columbia
- Florida
- Hawaii
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Maine
- Michigan
- Minnesota
- Missouri
- Montana
- North Carolina
- Nebraska
- Nevada
- Oklahoma
- Oregon
- Puerto Rico
- Texas
- Utah
- Virginia
- Washington
The words say it went outside the United States too.
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 Sep 28, 2020.
- FDA classified it on Nov 17, 2020.
- FDA’s Enforcement Report published it on Nov 25, 2020.
- FDA terminated it on Nov 2, 2022.
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: 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 8,612 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.