Terumo Recalls Sarns High-Flow Aortic Arch Cannula Kits Due to Foreign Substance
Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannula kits because a foreign substance was found on the outer surface of some connectors.
What this means for you
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 can 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 custom cardiopulmonary bypass catheter kit. The recall involves 133,793 units distributed nationwide in the United States and in 21 other countries. The affected catalog number is 80001-01, with specific lot codes MG21, MM04, NA24, ND21, NK01, NM31, and PA30.
During the production of one lot, the manufacturer discovered a foreign substance on the outer surface of some cannulae connectors. 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 was not specified in the provided source text.
This product is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Healthcare facilities and distributors should stop using the affected units and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- CUSTOM CPB CATHETER KIT-DR. 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
- Category
- Medical Device — Cardiovascular
- 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: 80001-01 and Lot code: MG21
- MM04
- NA24
- ND21
- NK01
- NM31
- and PA30.
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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