Agency classClass IIOur severity:High FDA (Devices)·Z-1929-2018·Announced 2018-05-30

Edwards IntraClude Intra-Aortic Occlusion Device Recalled for Potential Leak

Edwards Lifesciences is recalling 3,052 IntraClude Intra-Aortic Occlusion Devices due to a possible leak at the distal open end of the strain relief.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential leak in a medical device used for aortic occlusion, which poses a risk of harm if the device fails to maintain pressure, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Edwards Lifesciences, LLC is recalling 3,052 units of the IntraClude Intra-Aortic Occlusion Device, Model Number ICF100. The device is designed to occlude the ascending aorta and is packaged in a sterile barrier system.

The recall is due to a possible leak at the distal open end of the strain relief. This defect may cause medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta.

The affected units were distributed worldwide, including in the United States and various international countries. Specific lot numbers are listed in the agency's recall record. Healthcare facilities should contact Edwards Lifesciences for instructions on how to handle the recalled devices.

The recalled product

Product: Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta.
Manufacturer: Edwards Lifesciences, LLC
Category: Medical Device — Cardiovascular
Hazard: device-leak
loss-of-function
Affected units: 3,052

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot No. 60876468
60850885
6060850886
60850888
60850889
60850890
60887217
60887218
60887219
60887220
60930494
60934623
60934624
60934625
60972889
60972890
60972892
61014406
61014408
61014410

Distribution

Distributed in 30 states:

Same manufacturer · Edwards Lifesciences, LLC

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