Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device Recalled for Potential Damage
Edwards Lifesciences is recalling IntraClude Intra-Aortic Occlusion Devices due to potential damage near the hub that may cause blood leakage.
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 involves a medical device with a defect that may result in blood leakage, representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Edwards Lifesciences, LLC is recalling the IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. The recall involves 3,360 units that were distributed nationwide in the United States. The devices are packaged sterile and non-pyrogenic in a sealed, peel-type pouch and are intended for use in patients undergoing cardiopulmonary bypass.
The recall was initiated because of potential device damage on the strain relief near the hub area. This defect may result in blood leakage. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and consumers should stop using the affected devices immediately. The recall covers all lots within expiration, including specific lot numbers listed in the official FDA record Z-1758-2015. Users should contact Edwards Lifesciences for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients undergoing cardiopulmonary bypass.
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Cardiovascular
- Affected units
- 3,360
Distribution
Related recalls
Same manufacturer · Edwards Lifesciences, LLC
See all →- ModerateEdwards EVOQUE Tricuspid Delivery System Labeling Update for Valve Functionality
FDA (Devices) · 2026-05-20
- SevereFEM-FLEX II FEMII016A cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereFEM-FLEX II femoral arterial cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereFEM-FLEX II FEMII018A cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereOptisite OPTI18 arterial cannulas may have wire protruding from the body
FDA (Devices) · 2025-07-16
Same hazard · device damage
See all →- HighRENASYS EDGE 800ML Canister Recalled for Carbon Filter Damage Risk
FDA (Devices) · 2024-04-24
- SevereNimbus II Infusion Pump Systems Recalled for Multiple Potential Device Failures
FDA (Devices) · 2024-04-03
- HighBaxter peritoneal dialysis transfer sets may crack or leak with certain cleaners
FDA (Devices) · 2022-02-16
- HighCorin Unity Knee Augments Recalled Due to Packaging Damage and Sterility Loss
FDA (Devices) · 2021-10-06
- ModerateNovo Nordisk Recalls Saxenda Injection Samples Due to Temperature Abuse
FDA (Drugs) · 2021-04-21
Similar recalls
- HighEdwards IntraClude Intra-Aortic Occlusion Device Recalled for Potential Leak
FDA (Devices) · 2018-05-30
- SevereEdwards Lifesciences Recalls IntraClude Intra-Aortic Occlusion Devices Due to Balloon Rupture Risk
FDA (Devices) · 2019-06-19
- HighEdwards IntraClude Intra-Aortic Occlusion Device Recalled for Inter-Lumen Leak
FDA (Devices) · 2019-04-17
- HighEdwards PediaSat Oximetry Catheters Recalled for Potential Internal Leaks
FDA (Devices) · 2021-08-18
- HighEdwards PediaSat Oximetry Catheter Kit Recalled for Potential Internal Leaks
FDA (Devices) · 2021-08-18
- HighEdwards PediaSat Oximetry Catheter Kit Recalled for Internal Leak Risk
FDA (Devices) · 2021-08-18