Recall Z-0634-2009 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo TenderFlow Pediatric Arterial Cannulae, 3.3 mm (10Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813571. 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.
| Date | Feb 6, 2009 (initiated Oct 16, 2008) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 382 (160 plus 82 to US and 150 international) |
| Distribution | Worldwide Distribution --- including USA and countries of Australia, Belgium and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063618 | TENDERFLOW PERIATRIC ARTERIAL CANNULA Terumo Cardiovascular Systems Corp., Mar 13, 2007 |