Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance
Terumo is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors.
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 a foreign substance could be dislodged, representing a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling the Sarns High-Flow Aortic Arch Cannula, a non-sterile medical device used for perfusion of the ascending aorta during cardiopulmonary bypass surgery. The recall involves 133,793 units distributed nationwide in the United States and in 21 other countries.
The recall was initiated after Terumo discovered a foreign substance on the outer surface of some cannulae connectors during production. A preliminary investigation determined that the substance was likely deposited during the molding process and can be dislodged from the cannula surface. The exact composition of the particles has not been fully identified in the provided text.
Healthcare providers and facilities that have received these devices should stop using them and contact Terumo Cardiovascular Systems Corporation for instructions on how to return or dispose of the affected units. The affected catalog number is 88813030, and the specific lot codes are 0550551, 0568495, 0576844, 0586459, 0601958, 0626874, and 0635682.
The recalled product
- Product
- 24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 133,793
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 (7)
- Catalog number: 88813030 and Lot code: 0550551
- 0568495
- 0576844
- 0586459
- 0601958
- 0626874
- and 0635682.
Distribution
Part of a larger recall action
This product is one of 11 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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