The Recall Desk
ModerateFDA (Devices)·Z-1574-2022·Announced 2022-08-31

Vanta Clinician Programmer Software Cannot Connect with Multiple Implants

The Vanta Clinician Programmer Application may fail to connect with Vanta neurostimulators when a patient has multiple devices implanted. This prevents programming of pain therapy settings in patients with multiple implants.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported patient injuries or illnesses. The hazard is a communication failure that prevents device programming in the specific case of multiple implants, requiring corrective action but not presenting immediate danger.

Plain-English summary

The Vanta Clinician Programmer Application (Model A71200, Software Version 2.0.2455) is used to program Medtronic Vanta implantable neurostimulators for pain therapy. Approximately 4,386 copies of this application have been downloaded worldwide.

A potential communication issue may prevent the application from connecting with a Vanta Implantable Neurostimulator Model 977006 when a patient has more than one neurostimulator implanted. Unable to establish connection, the application cannot perform its programming function in these cases.

The software has been distributed worldwide, including across all 50 U.S. states, the District of Columbia, Puerto Rico, and numerous countries.

The recalled product

Product
Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
Manufacturer
Medtronic Neuromodulation
Hazard
  • connectivity-failure
  • programming-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Model A71200
  • Software Version 2.0.2455

Distribution

Distributed in 49 states:

  • 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