Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect
Terumo is recalling Sarns Aortic Cannulas because plastic flash at the tip may detach and harm patients 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 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 involves a risk-of-harm product where the hazard (detachment of plastic flash) has not yet been reported as an observed defect or injury, fitting the criteria for a High severity score.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 5,760 units of the Sarns Aortic Cannula (Catalog Number 5774, Lot Number 0595116). The recall was initiated because plastic flash was identified at the tip of certain lots of the device. This plastic flash has the potential to detach and contribute to an adverse patient effect.
The Sarns Aortic Cannula is a medical device indicated for the perfusion of the ascending aorta during cardiopulmonary bypass surgery, with a maximum indicated use of 6 hours. The affected units 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 determined that the product does not meet specifications. The condition could result in an unacceptable risk to patients. Users should stop using the affected lots and contact Terumo Cardiovascular Systems Corporation for further instructions.
The recalled product
- Product
- 24 Fr 8mm Soft Flow Ang W/L 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: 5774 and lot number: 0595116.
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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