Z-1840-2012Class II

SPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the...

Name: Z-1840-2012 SPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-05-09
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-05-09 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of SPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery on 2012-05-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1840-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-09
Posted: 2012-06-20
Terminated: 2013-07-11
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: SPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Terumo sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 9, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter advises customers to discontinue use of the affected product and to return the product to the firm. A Response Form was attached for customers to complete and return. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this recall.
Quantity in commerce: 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 , 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.
Product codes and lots: Catalog number: 64625 and Lot code: NA17, NC07A, NG06, NG06A, and NL19.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1840-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1832-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-20
Z-1833-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-20
Z-1834-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-20
Z-1835-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-20
Z-1836-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-20
Z-1837-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-20
Z-1838-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-20
Z-1839-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-20
Z-1840-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-20
Z-1841-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-20
Z-1842-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-20

Product code DWF

K770429Class IICannulae, Aortic, Arch, High Flow3M Health Care, Sarns / cleared 1977-03-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)