Z-1705-2019Class I

IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO...

Name: Z-1705-2019 IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO...
Creator: Edwards Lifesciences, LLC
Published: 2019-05-14
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2019-05-14 / Terminated / root cause: design

FDA source

Edwards Lifesciences, LLC began a recall of 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... on 2019-05-14. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1705-2019
Classification: Class I
Status: Terminated
Initiated: 2019-05-14
Posted: 2019-06-11
Terminated: 2024-04-23
Recalling firm: Edwards Lifesciences LLC
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.
Product code: DXC Clamp, Vascular
Reason for recall: 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 tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 6552
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 codes and lots: All lot numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1705-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1705-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-19	2019-06-11

Product code DXC

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)