Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2021 - (Recall #: Z-1522-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).

Product Classification:

Class II

Date Initiated: April 6, 2021

Date Posted: May 12, 2021

Recall Number: Z-1522-2021

Event ID: 87654

Reason for Recall:

There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).

Status: Ongoing

Product Quantity: 16,311 devices

Code Information:

All serial numbers

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated