Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect
Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.
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 medical device with a defect that could result in adverse patient effects, but no injuries or illnesses have been reported from the field, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 5,760 units of the Sarns Soft-Flow Aortic Cannula (Catalog Number 5843, Lot Number 0584961). The device is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery for up to 6 hours.
The recall was initiated because plastic flash was identified at the tip of certain lots. This plastic flash has the potential to detach and contribute to an adverse patient effect. The company determined that the product does not meet specifications and that this condition could result in an unacceptable risk.
The affected devices were distributed worldwide, including in the United States and internationally to Australia, the United Arab Emirates, Singapore, Malaysia, Belgium, Japan, and Canada. While this potential failure has not been reported from the field as an observed defect, the manufacturer is taking this action to ensure patient safety.
The recalled product
- Product
- 24 Fr 8mm Sft Flow Straight Wir The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 5,760
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)
- catalog number: 5843 and lot number: 0584961
Distribution
Part of a larger recall action
This product is one of 7 recalled by Terumo Cardiovascular Systems Corporation 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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