—#172949

Product

IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device occludes and vents the ascending aorta when the balloon is inflated.

FDA product code: DXC — Clamp, Vascular
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K113182, K132175, K163693
Affected lot / code info: All lot numbers.

Why it was recalled

Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and the device will need to be exchanged or operative strategy would need to change, including placement of an external cross-clamp, conversion to an open procedure, or performing the procedure under fibrillation.

Root cause (FDA determination)

Device Design

Action the firm took

On 05/14/19, the firm, Edwards, mailed "Urgent Product Recall" notices, via overnight service to its customers. The letter described the product, problem and actions to be taken. The letter informed customers of the recall and instructed them to do the following: 1) Review this field safety notice to understand the potential hazard. 2) Complete and return the attached Acknowledgement Form within five (5) business days of receiving this notice to Customer Service. 3) Complete and return the Product Reconciliation Form to Customer Service; return affected devices with the Return Goods Authorization (RGA) provided. 4) Distribute this notice within your organization or to any organization where the potentially affected devices have been transferred. If you have further distributed this product, notify your customers to the user level. Report any balloon failures to the recalling firm. Customers with additional questions were encouraged to call Customer Service Monday through Friday at (800) 424-3278, Option 1, from 8:00 AM - 4:00 PM Pacific Time. On 07/09/19, Urgent Product Recall notices were mailed via next-day service to customers informing them of the recall expansion.

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 1 Edwards Way, Irvine, California 92614-5688

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide) to states of: UT, GA, NJ, CA, OH, PA, AL, FL, TN, TX, ME, MA, IN, MS, NY, VA, MI, IL, CO, OR, WA, SC, AZ, SD, MO, CT, OK, NV, WV, WI, NC, MN, KY; and countries of: United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Colombia, Czech Republic, Germany, France, United Kingdom, Italy, Netherlands, Poland, Romania, and Sweden.

Timeline

Recall initiated: 2019-05-14
Posted by FDA: 2019-06-11
Terminated: 2024-04-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #172949. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.