—#75019

Product

Terumo TenderFlow Pediatric Arterial Cannulae, 4.7mm (14 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813576. 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.

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K063618
Affected lot / code info: Lot 0509241.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Road, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: Worldwide Distribution --- including USA and countries of Australia, Belgium and Canada.

Timeline

Recall initiated: 2008-10-16
Posted by FDA: 2009-02-06
Terminated: 2009-08-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #75019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.