Terumo Recalls Sarns Antegrade Cardioplegia Cannula Kits Due to Foreign Substance
Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannula kits because a foreign substance on the cannula tips can be dislodged during use.
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 Class II medical device with a risk of harm (foreign substance dislodgement) 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 Sarns Antegrade Cardioplegia Cannula kits, specifically the CPB Catheter Kit-DR Bartles. The recall involves 53,139 units distributed worldwide, including nationwide in the United States and in various international markets.
The recall was initiated because 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 catalog number is 80004-03, and affected lot numbers include MG14, MK16, MN15, NC07, NE18, NK01, NM31, PA30, and PD05. Healthcare providers should stop using these devices and contact Terumo CVS for instructions on return or replacement.
The recalled product
- Product
- CPB CATHETER KIT-DR BARTLES 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
- 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: 80004-03 and lot number: MG14
- MK16
- MN15
- NC07
- NE18
- NK01
- NM31
- PA30
- 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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