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Recall Observatory FDA recall evidence

Device product

18 Fr 6mm Sft Flow Angled Wire The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Z-0459-2013

November 21, 2012

Class II

Product summary

Firm
Terumo Cardiovascular Systems Corporation
Event
Event 63407
Status
Terminated
Classification
Class II
Quantity
5760 total
Official record key
device-enforcement:Z-0459-2013

Official wording

Reason: The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptabl

Code information: catalog number: 7071 and lot number: 0597322, 0602541, 0610241, 0615610, 0619197, 0620809, and 0620810.

Distribution pattern: Worldwide Distribution - USA including AL , CA , CO , DC , DE , FL , GA , IL , IN , KS , KY , LA , MA , MI , MO , MS , MT , NC , ND , NE , NH , NY , OH , PA , TN , TX , VA , and WI. Internationally to Australia, United Arab Emirates (UAE), Singapore, Malaysia, BELGIUM, Japan, and CANADA.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    does not meet specifications