Terumo Recalls Sarns Cardioplegia Cannula Kits Due to Foreign Substance
Terumo is recalling Sarns Antegrade Cardioplegia Cannula kits because a foreign substance was found on the inner surface of some 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 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 where a foreign substance could be dislodged and enter the patient's body, 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 specific lots of the Sarns Antegrade Cardioplegia Cannula, part of the CPB Catheter Kit-DR Vantright. The recall involves 53,139 units distributed worldwide, including nationwide in the United States and in various international countries.
The recall was initiated because Terumo identified a foreign substance on the inner surface of some cannula tips during production. Preliminary investigations indicate that this substance, likely deposited during the molding process, can be dislodged from the cannula surface. The exact composition of the substance is not specified in the source text.
Healthcare facilities and consumers should stop using the affected products immediately. The affected catalog number is 80004-02, and the specific lot numbers are MG07, MK02, MM11, MN15, MP13, ND28, NE25, NN21, and PA23. Users should contact Terumo Cardiovascular Systems for further instructions on returning or disposing of the recalled items.
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 (9)
- Catalog number: 80004-02 and lot number: MG07
- MK02
- MM11
- MN15
- MP13
- ND28
- NE25
- NN21
- and PA23.
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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