Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2021 - (Recall #: Z-1650-2021)

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:

Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies.

Product Classification:

Class II

Date Initiated: April 7, 2021

Date Posted: May 26, 2021

Recall Number: Z-1650-2021

Event ID: 87769

Reason for Recall:

The device may contain a manufacturing defect of a missing resistance spot weld (RSW).

Status: Terminated

Product Quantity: 2 units

Code Information:

Product Number: DTPB2D4, UDI: 00763000178215 Serial Numbers: RTO601595S and RTO601624S

Distribution Pattern:

US Nationwide distribution in the state of North Carolina.

Voluntary or Mandated:

Voluntary: Firm initiated