—#137174

Product

Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients undergoing cardiopulmonary bypass.

FDA product code: DXC — Clamp, Vascular
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K132175
Affected lot / code info: All lots within expiration. 59443555 59613944 59655681 59718185 59751955 59829691 59913251 59973802 59473497 59613945 59655682 59718186 59757492 59829692 59914824 59973803 59478792 59630641 59655683 59718187 59767963 59842135 59914825 59979641 59478793 59644480 59677638 59721969 59790316 59853386 59914826 59979642 59490124 59644481 59695842 59721970 59790317 59853387 59936991 59999093 59523568 59644482 59695843 59721971 59801106 59856575 59936992 60016315 59559537 59649627 59695844 59734231 59801107 59872381 59962951 60031031 59585111 59649628 59718182 59734232 59806707 59895500 59962952 59597667 59655679 59718183 59751953 59812135 59901268 59962953 59598246 59655680 59718184 59751954 59824839 59904370 59967598

Why it was recalled

Potential device damage on the strain relief near the hub area, which may result in blood leakage.

Root cause (FDA determination)

Device Design

Action the firm took

Urgent Medical Device Safety Notice letters were sent via Fed-Ex by May 05, 2015. As part of the customer instructions in the safety notice, customers were requested to review the notice to understand the potential hazard, complete and return the acknowledgement form, and forward copies of the Safety Notice to any organization where the potentially affected devices have been transferred. The device will only be distributed to customers who have returned the acknowledgement form. Questions should be directed to Edwards Customer Service at 800-424-3278.

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 12050 Lone Peak Pkwy, Draper, Utah 84020-9414

Distribution

Distribution pattern: Nationwide Distribution -- US, including the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia.

Timeline

Recall initiated: 2015-05-05
Posted by FDA: 2015-06-11
Terminated: 2017-12-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137174. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.