Z-1298-2012

Sarns Soft-Flow Aortic Cannula without suture flange Angled tip with luer port 80mm (24Fr) 00 with 3/8"...

Name: Z-1298-2012 Sarns Soft-Flow Aortic Cannula without suture flange Angled tip with luer port 80mm (24Fr) 00 with 3/8"...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-02-23
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-02-23 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Sarns Soft-Flow Aortic Cannula without suture flange Angled tip with luer port 80mm (24Fr) 00 with 3/8" connector,12" (31cm) long Product Usage: CTS Usage: The... on 2012-02-23. The reason FDA records is "During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball". 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-1298-2012
Status: Terminated
Initiated: 2012-02-23
Posted: 2012-03-23
Terminated: 2013-04-03
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Sarns Soft-Flow Aortic Cannula without suture flange Angled tip with luer port 80mm (24Fr) 00 with 3/8" connector,12" (31cm) long Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Terumo sent an URGENT MEDICAL DEVICE RECALL letter dated February 23, 2012 via Federal Express to all US customers. Terumo Foreign Affiliates received the recall notification via email on February 24th, 2012. The letters identified the affected products, reson for removal, potential hazard, affected population and actions to be taken. Customers were instructed to review the Medical Device Removal notice, assure that all users are aware of the notice, confirm receipt of this communication by faxing the attached Customer Response Form to the fax number provided or email to [email protected] and call Terumo CVS Customer Service for a Returned Goods Authorization (RGA) number. For questions call Terumo CVS Customer Service at 1-800-521-2818.
Quantity in commerce: 188,282 Cannulae and 248 Custom Tubing Packs
Distribution: USA Nationwide Distribution including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of: CANADA, CHILE, India, Japan, Singapore, AUSTRALIA, Malaysia, BELGIUM, BELGIUM, BRAZIL, CHILE, BRAZIL, BRAZIL, and Philippines.
Product codes and lots: catalog number: 5774 and lot numbers: 0551682, 0562327, 0567182, 0576283, 0581820, 0595116, 0598462, 0605197, 0620811, 0627377, 0631693, 0634182, and 0643837.

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 2026-09-05. View this recall on fda.gov (opens on fda.gov)