# FDA recall Z-1650-2021

> **Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)** · Class II · device recall initiated 2021-04-07.

## Product

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.

## Reason for recall

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

## Distribution

US Nationwide distribution in the state of North Carolina.

## Key facts

- **Recall number:** Z-1650-2021
- **Recalling firm:** Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-07
- **Report date:** 2021-05-26
- **Termination date:** 2024-08-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mounds View, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1650-2021

## Citation

> AI Analytics. FDA recall Z-1650-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1650-2021. Source: US FDA. Licensed CC0.

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