Terumo Advanced Perfusion Assembly Pump Guts — Class II medical device recall Z-1111-2020
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2020-02-19, distributed nationwide. These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut
| Recall number | Z-1111-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2020-01-10 |
| Classified | 2020-02-07 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2020-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | HK, IN, KR, TW |
| Quantity | 11 |
| Reason classes | device malfunction |
| Serial numbers | 880559, 880560, 882808, 882809, 882810, 882811, 882812, 882813, 885541, 885542, 885543 |
| Model numbers | 801805 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1111-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.