Edwards Lifesciences Recalls EMBOL-X Glide Protection System Due to Deformation
Edwards Lifesciences is recalling EMBOL-X Glide Protection Systems because the cannula tip may deform. The recall covers 12,034 units distributed in the US and Canada.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Edwards Lifesciences, LLC is recalling certain lots of the EMBOL-X Glide Protection System. The recall is due to deformation of the cannula tip. The affected model numbers include EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D, and EXGF24XL2D.
The EMBOL-X access device is indicated for the perfusion of the ascending aorta during short-term cardiopulmonary bypass surgery. The recall involves 12,034 units that were distributed nationwide in the United States and in Canada.
The source text does not specify the exact actions consumers or healthcare providers should take, nor does it report any specific injuries or illnesses associated with the deformation.
The recalled product
- Product
- Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D. The EMBOL-X access device is indicated for the perfusion of the ascending aorta…
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 12,034
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 (10)
- Model No: EXGF24D
- EXGF24LLD
- EXGF24MMD
- EXGF24SSD
- EXGF24XLD
- EXGF24XSD
- EXGFXS2D
- EXGF24SS2D
- EXGF24MM2D
- EXGF24LL2D and EXGF24XL2D.
Distribution
Distributed nationwide across the United States.
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