Terumo Recalls Sarns Soft-Flow Aortic Cannulas Due to Particulate
Terumo CVS is recalling Sarns Soft-Flow Aortic Cannulas because loose fiber particulate was found during inspection.
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 70 units of Sarns Soft-Flow Aortic Cannulas. The specific product is the 7.0 mm (21 Fr) OD model with a 3/8" connector and 14" length, indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
The recall was initiated after an in-process inspection identified loose fiber particulate that exceeded finished product specifications on certain lots. The affected lot number is 0677301.
The products were distributed worldwide, including the United States (specifically DC, MO, TX, OK, LA, MA, CA, WI, and MI) and Canada. Users should stop using the affected devices and contact the manufacturer for instructions.
The recalled product
- Product
- Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 70
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 5798 Lot Numbers 0677301
Distribution
Part of a larger recall action
This product is one of 4 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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