Terumo Recalls Sarns Aortic Arch Cannulas Due to Loose Fiber Particulate
Terumo CVS is recalling 120 units of Sarns Flexible Aortic Arch 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a manufacturing defect (loose fiber particulate) identified during inspection, fitting the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 120 units of Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector. The devices are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery and are intended for up to 6 hours of use.
The recall was initiated after an in-process inspection identified the presence of loose fiber particulate that exceeded finished product specifications. The affected units are identified by Part No. 144936 and Lot # 653821.
The recalled devices were distributed worldwide, including nationwide in the United States and in Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, the United Arab Emirates, and the United Kingdom. Healthcare facilities and distributors should stop using the affected devices and contact Terumo CVS for further instructions.
The recalled product
- Product
- Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector 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
- Category
- Medical Device — Cardiovascular
- Affected units
- 120
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. 144936
- Lot #: 653821
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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Similar recalls
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