Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2018 - (Recall #: Z-0407-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Medtronic CareLink Encore 29901 Programmer

Product Classification:

Class II

Date Initiated: October 2, 2018

Date Posted: November 14, 2018

Recall Number: Z-0407-2019

Event ID: 81300

Reason for Recall:

Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.

Status: Ongoing

Product Quantity: 4072 units

Code Information:

All Serial Numbers

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated