—#100267

Product

804117, Terumo Coronary Ostia cannula, 12 Fr, 10 (25 cm) long A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K822210
Affected lot / code info: Part Number 804117 Lot 0520484, 0528974, 0555870, 0565140, 0569078, 0584967, 0613859, 0618949, 0621707, 0626263, 0633299.

Why it was recalled

The presence of adhesive and/or skiving of plastic material observed inside the distal tip of the cannula, which could lead to particulate and/or decrease in the internal diameter. The plastic skiving may detach and enter the patient, embolizing the coronary vasculature. The potential risk due to decrease in the internal tip diameter is inadequate delivery of cardioplegia and/or prolonged procedu

Root cause (FDA determination)

Process control

Action the firm took

Terumo Cardiovascular Systems Corporation sent an URGENT MEDICAL DEVICE REMOVAL notice dated May 16, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken. The letter described the problem, the potiential hazard, and the action to be taken by the consignee. Consignees were instructed to discontinue use of the product and return all product to Terumo. The letter provided a list of alternate products to be used instead of the recalled products. Consignees with questions should call 1-800-521-2818 Monday through Friday 8AM to 6PM.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES (UAE), SINGAPORE, MALAYSIA, AND SOUTH AFRICA.

Timeline

Recall initiated: 2011-05-16
Posted by FDA: 2011-06-14
Terminated: 2012-03-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #100267. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.