Terumo Recalls Sarns Cardioplegia Cannulas Due to Foreign Substance
Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance on the inner surface of the tips can be dislodged during use.
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 criteria for a High severity rating.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling the Sarns Antegrade Cardioplegia Cannula. The recall was initiated after the manufacturer identified the presence of a foreign substance on the inner surface of some cannulae tips during production. The substance was likely deposited during the molding process, and preliminary investigation found that it can be dislodged from the cannula surface.
The recall affects 53,139 units of the Sarns Antegrade Cardioplegia Cannula, specifically catalog number 71415-03 and lot numbers NC21, NF16, NL26, PA30, PC13, and PD05. These devices 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 cardiopulmonary bypass procedures.
The affected products were distributed worldwide, including nationwide in the United States and in various international locations. Healthcare facilities and users should stop using the affected devices and contact Terumo Cardiovascular Systems Corporation for further instructions.
The recalled product
- Product
- INDIANA/OHIO HEART 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…
- 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 (6)
- Catalog number: 71415-03 and lot numbers: NC21
- NF16
- NL26
- PA30
- PC13
- 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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