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IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5… recallZ-1705-2019 · Edwards Lifesciences, LLC · initiated May 14, 2019

Class I Terminated All recalls posted in June 2019

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Edwards Lifesciences, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1705-2019
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
May 14, 2019
Posted by the FDA
Jun 11, 2019
Recalling firm
Edwards Lifesciences, LLC
Quantity
6552
Product code
DXC
FDA submissions
K113182, K132175, K163693
Distribution
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.

Product description

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.

Code information (models, lots, serial numbers)

All lot numbers.

Other devices under the same FDA submission

2 devices cleared under K113182, K132175, K163693 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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