Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2021 - (Recall #: Z-1525-2021)

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:

Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Azure family: Azure XT DR MRI SureScan", Azure S DR MRI SureScan, Azure XT SR MRI SureScan, Azure S SR MRI SureScan. 2. Astra family: Astra XT DR MRI SureScan, Astra XT SR MRI SureScan.

Product Classification:

Class II

Date Initiated: April 6, 2021

Date Posted: May 12, 2021

Recall Number: Z-1525-2021

Event ID: 87662

Reason for Recall:

A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.

Status: Ongoing

Product Quantity: 575815 units

Code Information:

all codes

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated