Z-1574-2022 Class II Ongoing
FDA device recall Z-1574-2022 was initiated by Medtronic Neuromodulation on Jul 26, 2022 and is designated Class II. Reason for recall: Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta Implantable Neurostimulator (INS) Model 977006 when a… The recall status is ongoing. Affected quantity: 4386 downloaded software applications.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 31, 2022
- Initiation Date
- Jul 26, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4386 downloaded software applications
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Puerto Rico. The countries of Austria, Belgium, Canada, Canary Islands, Cayman Islands, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Poland, Portugal, San Marino, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1574-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026