Z-0631-2009

Terumo TenderFlow Pediatric Arterial Cannulae, 2.0mm (6Fr) OD, with 1/4 inch non-vented connector, 9 inch...

Name: Z-0631-2009 Terumo TenderFlow Pediatric Arterial Cannulae, 2.0mm (6Fr) OD, with 1/4 inch non-vented connector, 9 inch...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2008-10-16
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2008-10-16 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo TenderFlow Pediatric Arterial Cannulae, 2.0mm (6Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813568. The TenderFlow... on 2008-10-16. The reason FDA records is "The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0631-2009
Status: Terminated
Initiated: 2008-10-16
Posted: 2009-02-06
Terminated: 2009-08-04
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo TenderFlow Pediatric Arterial Cannulae, 2.0mm (6Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813568. The TenderFlow (TM) Pediatric Arterial 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 introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent Medical Device Recall letter dated 10/16/08 was sent to consignees advising them of the problem; requesting that they immediately verify whether or not they had unused cannulae with the affected lot numbers; requesting that they isolate any affected product to prevent use; complete the Customer Response Form, indicate on form if it is medically necessary to use product without introducer; fax Customer Response Form to Terumo CVS at the number listed; and Terumo CVS would contact customers to arrange for the return of unused product. The letter stated that credit would be issued for any unused TenderFlow cannulae that were returned. The quantities to be returned should be indicated on the Customer Response Form. Consignees were advised that, if it was medically necessary to use the affected cannulae, they should be used without the introducer and in accordance with instructions for such use.
Quantity in commerce: 178 (110 plus 58 samples to US and 10 international)
Distribution: Worldwide Distribution --- including USA and countries of Australia, Belgium and Canada.
Product codes and lots: Lot numbers 0501639 and 0512002.

Product code DWF

K063618Class IITenderflow Periatric Arterial CannulaTerumo Cardiovascular Systems Corp. / cleared 2007-03-13

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)