CLASS II Device recall · Reported 27 Jun 2012 · FDA Enforcement Report

Sarns Flexible Arterial Cannula recalled

Terumo Cardiovascular Systems is recalling Sarns Flexible Arterial Cannula: With 3/8" Connector,suture Ring, 5" Long, distributed nationwide in the US. The recall was initiated on 9 May 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog number: 13030 and Lot code: 0553041, 0555967, 0557330, 0559885, 0562990, 0564951, 0567668, 0570456, 0571580, 0575365, 0580822, 0583186, 0585529, 0590858, 0593455, 0596125, 0600250, 0605504, 0609198, 0614183, 0620033, 0623325, 0626858, 0634096, 0636271, 0638011, 0640980, 0650900, 0653232, and 628985C.

Quantity recalled133,793 (each)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1837-2012
FDA event ID: 61742
Recalling firm: Terumo Cardiovascular Systems, Ann Arbor, MI
Classification: Class II
Status: Terminated
Recall initiated: 9 May 2012
FDA classified: 20 Jun 2012
Reported: 27 Jun 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

9 May 2012	Recall initiated by company
20 Jun 2012	Classified by FDA	+42 days
27 Jun 2012	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Where it was distributed

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.

Nationwide Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Hawaii Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota

Stores named: CVS

Questions about this recall

Is Sarns Flexible Arterial Cannula: With 3/8" Connector,suture Ring, 5" Long recalled?

Yes. Terumo Cardiovascular Systems recalled Sarns Flexible Arterial Cannula: With 3/8" Connector,suture Ring, 5" Long on 9 May 2012. The recall is Class II and its status is Terminated. Recall number Z-1837-2012.

Why was it recalled?

Which lots are affected?

Catalog number: 13030 and Lot code: 0553041, 0555967, 0557330, 0559885, 0562990, 0564951, 0567668, 0570456, 0571580, 0575365, 0580822, 0583186, 0585529, 0590858, 0593455, 0596125, 0600250, 0605504, 0609198, 0614183, 0620033, 0623325, 0626858, 0634096, 0636271, 0638011, 0640980, 0650900, 0653232, and 628985C.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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