Terumo Recalls Sarns Cardioplegia Cannulas Due to Foreign Substance
Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some tips that can be dislodged.
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 medical device with a potential for harm (dislodged foreign substance) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling the Sarns Antegrade Cardioplegia Cannula. The recall involves 53,139 units distributed worldwide, including the United States and various international markets. The affected products are identified by catalog number 80003-02 and specific lot numbers.
The recall was initiated because Terumo CVS identified a foreign substance on the inner surface of some cannulae 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.
Healthcare providers and facilities that have received these devices should stop using them and contact Terumo CVS for further instructions. The devices are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart during cardiopulmonary bypass procedures.
The recalled product
- Product
- CPB CATHETER KIT- DR HENDRICKSO 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 (10)
- Catalog number: 80003-02 and lot number: MH12
- MK30
- MP06
- NA31
- NE18
- NF23
- NM31
- NN28
- NP19
- and PD05.
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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