Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2022 - (Recall #: Z-1480-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)

Product Classification:

Class II

Date Initiated: November 5, 2020

Date Posted: August 3, 2022

Recall Number: Z-1480-2022

Event ID: 90429

Reason for Recall:

Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.

Status: Ongoing

Product Quantity: 3 units

Code Information:

GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S

Distribution Pattern:

US Nationwide distribution in the states of Indiana and CA.

Voluntary or Mandated:

Voluntary: Firm initiated