# FDA recall Z-1111-2020

> **Terumo Cardiovascular Systems Corporation** · Class II · device recall initiated 2020-01-10.

## Product

Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting.

## Reason for recall

These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed.  The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of CT, FL, LA, MA, MI, NY, and TX. Countries of Hong Kong, India, South Korea, and Taiwan.

## Key facts

- **Recall number:** Z-1111-2020
- **Recalling firm:** Terumo Cardiovascular Systems Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-10
- **Report date:** 2020-02-19
- **Termination date:** 2020-05-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ann Arbor, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1111-2020

## Citation

> AI Analytics. FDA recall Z-1111-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-1111-2020. Source: US FDA. Licensed CC0.

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