Terumo Recalls Sarns Antegrade 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 cannula tips that can be dislodged.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of a dislodgable foreign substance in a device used during cardiac surgery poses a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling the Sarns Antegrade Cardioplegia Cannula, specifically the X-COATED SMALL PATIENT PACK (Catalog number 71936-02, Lot number PC06). The recall involves 53,139 units distributed worldwide, including nationwide in the United States and in various international markets.
The recall was initiated after Terumo CVS identified the presence of 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. Healthcare facilities and distributors should stop using the affected units and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- X-COATED SMALL PATIENT PACK 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
- 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 (1)
- Catalog number: 71936-02 and lot number: PC06
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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