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Lower risk Medical device recall · FDA · Published September 23, 2021

Medtronic CPA Software A610 Recall: Software Anomaly Risk

Medtronic recalls Clinician Programmer Application software versions 3.0.1048-1081 for potential software anomalies. Affected users should check their software version and contact Medtronic for updates.

🇺🇸 FDA recall #Z-0201-2022Medical deviceMedtronic Neuromodulation ›
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Contact the company

Recalling firmMedtronic Neuromodulation7000 Central Ave Ne · Minneapolis, MN 55432-3568
✎ GovInfoNow plain-language explainer

Medtronic is recalling specific versions of their Clinician Programmer Application software (A610) due to a possible software anomaly. This could affect device programming safety, though the recall does not specify immediate harm. Read more at govinfonow.com/recall/61759-medtronic-cpa-software-a610-recall-software-anomaly-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61759-medtronic-cpa-software-a610-recall-software-anomaly-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0201-2022

Cite this page

“Medtronic CPA Software A610 Recall: Software Anomaly Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61759-medtronic-cpa-software-a610-recall-software-anomaly-risk. Based on FDA recall #Z-0201-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0201-2022%22&limit=1).

The FDA announced on 2021-09-23 that Medtronic Neuromodulation is recalling the Clinician Programmer Application (CPA) model A610 due to a software anomaly. The agency issued recall number Z-0201-2022 for the device.

How to tell if you have it

  • Clinician Programmer Application (CPA) model A610
  • version 3.0.1048
  • version 3.0.1057
  • version 3.0.1062
  • version 3.0.1081

The hazard

According to the FDA, a software anomaly may occur with the clinician programmer application.

Context

GovInfoNow's records show Medtronic Neuromodulation has 45 other recalls on record since 2017-08-09. Other recent recalls of similar products include Medtronic SynchroMed Flex Infusion Software Issue (2026-04-08), Medtronic Vanta CP App Software Recall (2025-12-03), Edan Central Monitoring System Recall (2025-10-24), Fresenius Medical Care 5008X CAREsystem Recall (2025-10-25), and Edan Central Monitoring System Recall (2025-10-24).

How to tell if you have this one

Check if your software version is 3.0.1048, 3.0.1057, 3.0.1062, or 3.0.1081. The software is part of Medtronic's Clinician Programmer Application (CPA) model A610.

  • Brand
    Medtronic Neuromodulation
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Identify your software version by checking the Clinician Programmer Application (CPA) model A610 version number.

  2. Contact Medtronic

    Reach out to Medtronic for guidance on updating or replacing the software.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Australia, New Zealand, Canada, Europe, India, Japan, Korea, Middle East, Latin America, Africa, SE Asia and China.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 48 days after the firm started it.

1. Firm started the recall: Sep 23, 202112. FDA classified it Class II: Nov 4, 202123. Published in FDA’s Enforcement Report: Nov 10, 202132021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0201-2022 (September 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0201-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA