Z-0458-2013Class II

24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta...

Name: Z-0458-2013 24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-11-21
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-11-21 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of 24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These... on 2012-11-21. FDA classified it as Class II and gives the reason as "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...". 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-0458-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-21
Posted: 2012-12-03
Terminated: 2013-04-23
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: 24 Fr 8mm Sft Flow Straight 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.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Process design
Action: TERUMO sent an URGENT MEDICAL DEVICE RECALL letter dated September 20, 2012, to all affected customers. The letter identified the product, the problem, and the aciton to be taken by the customer. Customers were instructed to remove this cannulae from circulation and return them for credit. Customers with questions should call 1-800-521-2818. For questions regarding this recall call 734-741-6173.
Quantity in commerce: 5760 total
Distribution: 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.
Product codes and lots: catalog number: 5847 and lot number: 0582251 and 0586068

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0458-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0456-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-03
Z-0457-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-03
Z-0458-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-03
Z-0459-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-03
Z-0460-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-03
Z-0461-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-03
Z-0462-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-03

Product code DWF

K934127Class IISarns Low Jetting Aortic Arch Cannula3M Health Care, Sarns / cleared 1994-02-22

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)