—#103985

Product

Sarns Rigid Intracardiac Sucker. The subject device is a single use, sterile device with a 7.0 mm (21 FR) tip and 1/4 connector

FDA product code: DTS — Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Catalog number 4300 and CV-4300

Why it was recalled

Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intracardiac Sucker.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On 9/13/2011 Terumo sent a letter entitled "URGENT MEDICAL DEVICE REMOVAL" to its customers that included the name and description of the device, lot numbers, the potential hazard, correction, the reason for the recall and instructions. Customers are to review the notice, ensure that all users are aware of the issue, and a recall response form to be completed and returned. Customers are to call Terumo CVS Customer Service to obtain a Return Goods Authorization number. The letter also included MedWatch reporting information and stated that Customers with questions should call 1-800-521-2818.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- USA, Belgium, Australia, Mexico, and Japan.

Timeline

Recall initiated: 2011-09-13
Posted by FDA: 2011-10-17
Terminated: 2012-12-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103985. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.