# FDA recall Z-1872-2021

> **Medtronic Perfusion Systems** · Class II · device recall initiated 2021-04-29.

## Product

Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.

## Reason for recall

Specific lots may have been manufactured with insufficient or incomplete welds.

## Distribution

US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX.  There was no foreign/government/military distribution.

## Key facts

- **Recall number:** Z-1872-2021
- **Recalling firm:** Medtronic Perfusion Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-29
- **Report date:** 2021-06-23
- **Termination date:** 2023-03-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brooklyn Park, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1872-2021

## Citation

> AI Analytics. FDA recall Z-1872-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1872-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*