Terumo Recalls Sarns Soft-arc Aortic Cannula Due to Loose Fiber Particulate
Terumo CVS is recalling 20 units of Sarns Soft-arc Aortic Cannulas because in-process inspections found loose fiber particulate exceeding specifications.
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 high-risk medical device used in surgery where particulate contamination poses a risk of harm, but the source text does not report any specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 20 units of Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare (Part No. 16094, Lot #: 655235). The recall was initiated after an in-process inspection identified the presence of loose fiber particulate that exceeded finished product specifications.
The affected devices are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery, with a maximum indicated use of up to 6 hours. The recall covers units distributed nationwide in the United States and in several international countries, including Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, the United Arab Emirates, and the United Kingdom.
Healthcare facilities and consumers should stop using the affected devices and contact Terumo Cardiovascular Systems Corporation for further instructions or replacement.
The recalled product
- Product
- Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare Product Usage: The 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
- 20
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 (2)
- Part No. 16094
- Lot #: 655235
Distribution
Part of a larger recall action
This product is one of 13 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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