Edwards Lifesciences Recalls EZ Glide Aortic Cannula Due to Connector Separation Risk
Edwards Lifesciences is recalling EZ Glide Aortic Cannulae because the cannula may separate from its connector, potentially causing significant blood loss during surgery.
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 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 recall involves a medical device defect that could result in significant blood loss during a surgical procedure, which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk structural defects in medical devices.
Plain-English summary
Edwards Lifesciences, LLC is recalling 62,431 units of EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector. The product is a sterile, prescription-only aortic perfusion cannula intended for the perfusion of the ascending aorta during short-term cardiopulmonary bypass procedures.
The recall was initiated because there is a possibility that the cannula may separate from its connector. This separation could potentially cause a breach of the circuit during cardiopulmonary bypass, which could result in significant blood loss.
The affected units were distributed worldwide, including nationwide distribution in the United States and in numerous countries across Europe, Asia, the Americas, and the Middle East. The specific lot numbers affected are listed in the structured product information. Healthcare providers and facilities should stop using the affected devices and contact Edwards Lifesciences for further instructions.
The recalled product
- Product
- EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174182), EZC21TA (00690103174199), EZC24A (00690103714401), EZC24TA…
- Manufacturer
- Edwards Lifesciences, LLC
- Affected units
- 62,431
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 #s: 203876 207654 217024 226788
- 205724
- 207655
- 217025
- 226938
- 205775
- 208823
- 217048
- 227494
- 205868
- 208893
- 218185
- 227886
- 205920
- 208894
- 218457
- 228009
- 205921
- 209901
- 218539
Distribution
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