Z-0667-2013Class II

Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long The...

Name: Z-0667-2013 Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long The...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2013-01-07
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2013-01-07 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns&amp;quot; High Flow Aortic Arch Cannula... on 2013-01-07. FDA classified it as Class II and gives the reason as "Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the...". 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-0667-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-07
Posted: 2013-01-11
Terminated: 2013-08-26
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns&amp;quot; High Flow Aortic Arch Cannula and Sarns&amp;quot; Flexible Arterial Cannulae are 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: Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: TERUMO sent an URGENT MEDICAL DEVICE RECALL notification to all consignees on January 7, 2013. Terumo CVS is advising users to discontinue use and return all affected cannulae in inventory. Terumo CVS will issue credit for returned cannulae. Terumo CVS providied a list of marketed devices that can be used as alternatives. Contact Terumo CVS Customer Service with questions or concerns: 800- 521- 2818 Monday Friday, 8 AM - 6 PM EST For questions regarding this recall call 734-741-6173.
Quantity in commerce: 6830 total all products
Distribution: Nationwide and worldwide: AL , AR , AZ , CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , ME , MI, MO , NC , ND , NV , NY , OH , OK , PA , SD , TN , TX , UT , VA , WA , and WI. Bahrain, BRAZIL, CANADA, CHILE, Honduras, Singapore, Taiwan, Trinidad and Tobago, and UNITED ARAB EMIRATES (UAE).
Product codes and lots: Lot number: 0677284 and Catalog number: 13020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0667-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0666-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-11
Z-0667-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-11
Z-0668-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-11
Z-0669-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-11
Z-0670-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-11
Z-0671-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-11

Product code DWF

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 2026-09-06. View this recall on fda.gov (opens on fda.gov)