Edwards Recalls EndoReturn Arterial Cannula Due to Component Error
Edwards Lifesciences is recalling specific lots of the EndoReturn Arterial Cannula because an incorrect component was used, which may cause performance issues with the IntraClude device.
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 source describes a performance problem with a specific device but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Edwards Lifesciences, LLC is recalling 855 units of the EndoReturn Arterial Cannula, models ER21B and ER23B. The recall covers specific lots distributed nationwide in the United States, as well as in Canada and at VA sites.
The recall was initiated because certain lots were built with an incorrect component. This defect can create a performance problem when the cannula is used with the IntraClude IntraAortic Occlusion device.
Healthcare providers and facilities should identify the affected lots and stop using the recalled devices. The source text does not specify a particular consumer action for the general public, as this is a medical device used in clinical settings.
The recalled product
- Product
- Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector hub. The ThruPort catheter introducer sheath kit includes a wire reinforced…
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 855
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 (15)
- Model ER21B Lots: 59496984
- 59516933
- 59516936
- 59531385
- 59531386
- 59543708 Model ER23B Lots: 59464327
- 59484349
- 59484350
- 59484351
- 59512146
- 59513272
- 59516940
- 59534430
- 59535739
- 59541763
Distribution
Distributed nationwide across the United States.
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