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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns highflow aortic arch cannula

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 Class 2 Device Recall Sarns highflow aortic arch cannulasee related information
Date Initiated by FirmJanuary 07, 2013
Date PostedJanuary 11, 2013
Recall Status1 Terminated 3 on August 26, 2013
Recall NumberZ-0670-2013
Recall Event ID 64007
510(K)NumberK083301 K770429 K771499 
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
ProductSarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Code Information Lot number: 0680122, 0680751and Catalog number: 12325
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact
734-741-6173
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionTERUMO 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 Commerce6830 total all products
DistributionNationwide 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).
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DWF
510(K)s with Product Code = DWF
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