FDA recall Z-0771-2025

Medtronic Neuromodulation · Class II · device

Product

SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B

Reason for recall

Software issues were identified in application version 2.x.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2024-11-21
Report date: 2025-01-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0771-2025