ModerateClass IITerminated

FDA Devices recall · Reported February 19, 2020

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 in

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on February 19, 2020. Severity: Moderate. Recall number: Z-1111-2020.

Q: Where was the recalled product distributed?

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..

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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 atypic…

Recall #: Z-1111-2020
Affected scope: 11
Initiated: January 10, 2020

Compiled from official public sources by the publisher. · Updated September 2026

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Terumo Cardiovascular Systems Corporation recalled Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usa… - a moderate-severity action.

Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usa… was recalled by Terumo Cardiovascular Systems Corporation in February 19, 2020. Reason: These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknu…. Check the official notice for the remedy. Verify recall #Z-1111-2020 with the FDA Devices before acting.

The recall

Terumo Cardiovascular Systems Corporation issued this moderate-severity FDA Devices recall-These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknu….

Moderate
severity level: 11 units
affected scope: Class II
classification: February 19, 2020
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1111-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1111-2020
Date reported	February 19, 2020
Date initiated	January 10, 2020
Recalling firm	Terumo Cardiovascular Systems Corporation
Firm location	Ann Arbor, MI
Affected scope	11
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.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

11 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1111-2020) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 19, 2020. Severity: Moderate. Recall number: Z-1111-2020.

Where was the recalled product distributed? ▼

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..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported February 19, 2020. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026