Terumo Recalls Sarns Antegrade Cardioplegia Cannula Due to Foreign Substance
Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulae because a foreign substance was found on the inner surface of some tips that could be dislodged.
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 where a foreign substance can be dislodged, posing a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling the Sarns Antegrade Cardioplegia Cannula. The recall involves 53,139 units distributed worldwide, including nationwide in the United States and in various international markets. The affected products are identified by catalog number 80001-01 and specific lot numbers.
During production, Terumo CVS identified a foreign substance on the inner surface of some cannulae tips. A preliminary investigation determined that this substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, though its exact composition is not specified in the source text.
The Sarns Antegrade Cardioplegia Cannula is indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, vent the left heart, and aspirate air from the aorta during cardiopulmonary bypass procedures. Users should stop using the affected devices and contact Terumo CVS for further instructions.
The recalled product
- Product
- CUSTOM CPB CATHETER KIT-DR. Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during c
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 53,139
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 number: MG21
- MM04
- NA24
- ND21
- NK01
- NM31
- and PA30.
Distribution
Part of a larger recall action
This product is one of 20 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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