24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae…

Recall #: Z-1839-2012
Affected scope: 133,793 (each)
Initiated: May 9, 2012

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

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Terumo Cardiovascular Systems Corporation recalled 24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated … - a moderate-severity action.

24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated … was recalled by Terumo Cardiovascular Systems Corporation in June 27, 2012. Reason: During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terum…. Check the official notice for the remedy. Verify recall #Z-1839-2012 with the FDA Devices before acting.

The recall

Terumo Cardiovascular Systems Corporation issued this moderate-severity FDA Devices recall-During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terum….

Moderate
severity level: Class II
classification: June 27, 2012
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1839-2012 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

24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Reason for recall

During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the parti

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-1839-2012
Date reported	June 27, 2012
Date initiated	May 9, 2012
Recalling firm	Terumo Cardiovascular Systems Corporation
Firm location	Ann Arbor, MI
Affected scope	133,793 (each)
Distribution	Worldwide Distribution-USA (nationwide) including the states of AL , AR , AZ, CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , MD , ME , MI , MI , MN , MO , MT , NC , ND , NE , NH , NJ , NM , NV , NY , OH , OK , OR , PA , …

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

What to do with this recall

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

Check the recall number (Z-1839-2012) and product description against the item you own. Search the archive
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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? ▼

24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 133,793 (each).

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on June 27, 2012. Severity: Moderate. Recall number: Z-1839-2012.

Where was the recalled product distributed? ▼

Distribution: Worldwide Distribution-USA (nationwide) including the states of AL , AR , AZ, CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , MD , ME , MI , MI , MN , MO , MT , NC , ND , NE , NH , NJ , NM , NV , NY , OH , OK , OR , PA , RI , SC , SD , TN , TX , UT , VA , WA , WI, and WY and the countries of Australia, Belgium, Brazil, Canada, Chile, Germany, Honduras, Hong Kong, India, Japan, Mauritius, Nicaragua, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates (UAE), and Vietnam..

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.

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This recall: FDA Devices, reported June 27, 2012. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026