Edwards Lifesciences Recalls Fem-Flex Femoral Arterial Cannulas Due to Cracks
Edwards Lifesciences is recalling two lots of Fem-Flex Femoral Arterial Cannulas because cracks were found in the t-connectors during product evaluation.
What this means for you
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 structural defect (cracks) in a medical device used for cardiopulmonary bypass, which poses a risk of harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Edwards Lifesciences, LLC is recalling two lots of Duraflo Cannulas, specifically the Fem-Flex Femoral Arterial Cannula with Duraflo Coating (DIITFA02225). The recall is due to reported complaints involving cracks in the t-connector of the devices, which were confirmed during product evaluation.
The affected product is a sterile, prescription-only medical device intended for single use. It is designed for rapid femoral venous and arterial access for short-term cardiopulmonary bypass in pediatric or adult populations. The specific lot number is 59388992 with an expiry date of 1/1/16.
The recall involves 80 units that were distributed nationwide. Healthcare providers and facilities should stop using the affected devices and contact Edwards Lifesciences for further instructions.
The recalled product
- Product
- Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards Lifesciences femoral access cannulae are intended for use in situations which require rapid femoral venous and arterial acce
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Cardiovascular
- Affected units
- 80
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)
- Lot number 59388992 expiry 1/1/16
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Edwards Lifesciences, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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