Z-1929-2018Class II

Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model...

Name: Z-1929-2018 Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model...
Creator: Edwards Lifesciences, LLC
Published: 2018-03-30
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2018-03-30 / Terminated

FDA source

Edwards Lifesciences, LLC began a recall of Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending... on 2018-03-30. FDA classified it as Class II and gives the reason as "Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1929-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-30
Posted: 2018-05-24
Terminated: 2023-11-29
Recalling firm: Edwards Lifesciences LLC
Product: Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta.
Product code: DXC Clamp, Vascular
Reason for recall: Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta.
FDA root cause: Under Investigation by firm
Action: Customers were notified on about 03/30/2018 via an Urgent Medical Device Safety Notice. Instructions included to review the field safety notice and understand the potential hazard, review the recall with appropriate clinical staff at their institution, complete and return the acknowledgement form, and distribute the notification within the organization where potentially affected devices may have been transferred. Questions can be directed to Edwards Customer Service, Monday through Friday at 800-424-3278 form 8:00 AM - 4:00 PM Pacific Time.
Quantity in commerce: 3,052 units total
Distribution: Worldwide Distribution -- USA, to the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MI, MS, MO, NV, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV; and, the countries of to Australia, Austria, Belgium, Canada, Colombia, Czech Republic, France, Germany, Israel, Italy, Luxembourg, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
Product codes and lots: Lot No. 60876468, 60850885, 6060850886, 60850888, 60850889, 60850890, 60887217, 60887218, 60887219, 60887220, 60930494, 60934623, 60934624, 60934625, 60972889, 60972890, 60972892, 61014406, 61014408, 61014410, 61014411, 61050171, 61050172, 61078031, 61078032, 61097633, 61139239, 61139240, 61139241, 61139242, 61184964, 61184965, 67784966, 61184967, 61204586, 61204587, 61259626, 61259627, 61259628, and 61259629.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1929-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1929-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-24

Product code DXC

K163693Class IIIntraClude Intra-Aortic Occlusion DeviceEdwards Lifesciences, LLC / cleared 2017-01-26

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)