Agency classClass IIOur severity:High FDA (Devices)·Z-1887-2012·Announced 2012-07-04

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 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 dislodging foreign material during a surgical procedure, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 53,139 units of the Sarns Antegrade Cardioplegia Cannula (Catalog number: 74302, Lot number: PD19). The recall was initiated after the manufacturer identified a foreign substance on the inner surface of some cannula 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 affected 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 recall covers units distributed worldwide, including nationwide distribution in the United States and in countries such as Belgium, Brazil, Japan, and Mexico.

The source text does not specify the exact composition of the foreign substance or provide specific instructions for consumers or healthcare providers on how to handle the recalled units. No illnesses or injuries are reported in the provided text.

The recalled product

Product: X-COATED H/L PK W/FX15RW40 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: foreign-object
contamination
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: 74302 and lot number: PD19

Distribution

Distributed nationwide across the United States.

The notice also names 29 states specifically:

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.

See all 20 products in this recall →

Same manufacturer · Terumo Cardiovascular Systems Corporation

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Same hazard · foreign object