Edwards Lifesciences Recalls IntraClude Intra-Aortic Occlusion Devices Due to Balloon Rupture Risk
Edwards Lifesciences is recalling IntraClude Intra-Aortic Occlusion Devices because the balloon may rupture during cardiopulmonary bypass, potentially obscuring the operative site and requiring a change in surgical strategy.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, which mandates a minimum severity score of 4 per the rubric. The hazard involves a structural failure (balloon rupture) during a critical surgical procedure that could require significant changes to the operative strategy.
Plain-English summary
Edwards Lifesciences, LLC is recalling 6,552 units of the IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm). The device is indicated for use in patients undergoing cardiopulmonary bypass to occlude and vent the ascending aorta. The recall covers all lot numbers and includes devices distributed nationwide in the United States and in 17 other countries, including Canada, the United Kingdom, and Germany.
The recall was initiated due to the possibility of balloon rupture. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, and the operative site may be obscured. In such an event, the device would need to be exchanged, or the operative strategy would need to change. This could include the placement of an external cross-clamp, conversion to an open procedure, or performing the procedure under fibrillation.
Healthcare providers and facilities that have received these devices should stop using them and contact Edwards Lifesciences for further instructions. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of the product will cause serious adverse health consequences or death.
The recalled product
- 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
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Cardiovascular
- Affected units
- 6,552
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 (1)
- All lot numbers.
Distribution
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