Terumo Recalls Sarns Antegrade Cardioplegia Cannula Kits Due to Foreign Substance
Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannula kits because a foreign substance was found on the inner surface of some cannula tips that could dislodge.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is Class II. The hazard involves a dislodgable foreign substance in a critical surgical device used during cardiopulmonary bypass, which poses a significant risk of injury or adverse health consequences, meeting the criteria for a Severe rating.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling the Sarns Antegrade Cardioplegia Cannula, part of the CPB Catheter Kit-DR Vantright. The recall affects 53,139 units distributed worldwide, including nationwide in the United States and in various international markets.
The recall was initiated after Terumo CVS identified a foreign substance on the inner surface of some cannula tips during production. 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.
These devices are 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. Affected units are identified by Catalog number 80004-03 and lot number NP20. Healthcare facilities should stop using these devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- CPB CATHETER KIT-DR VANTRIGHT 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…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- 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 (1)
- Catalog number: 80004-03 and lot number: NP20
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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