Agency classClass IIOur severity:High FDA (Devices)·Z-1890-2012·Announced 2012-07-04

Terumo Recalls Sarns Antegrade Cardioplegia Cannula Kits Due to Foreign Substance

Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannula kits because a foreign substance was found on the inner surface of some cannula tips that could 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 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 specific lots of the Sarns Antegrade Cardioplegia Cannula, part of the CPB Catheter Kit - Dr Owen. The recall affects 53,139 units distributed worldwide, including nationwide in the United States and in various international markets.

The recall was initiated after 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.

Healthcare facilities and distributors should stop using the affected products immediately. The affected catalog number is 80002-03, and the specific lot numbers are MH12, MK30, MP06, NE18, NM31, and NN28. Users should contact Terumo CVS for further instructions on returning or disposing of the recalled items.

The recalled product

Product: CPB CATHETER KIT- DR OWEN 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-substance
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: 80002-03 and lot number: MH12
MK30
MP06
NE18
NM31
and NN28.

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 substance