Agency classClass IIOur severity:High FDA (Devices)·Z-1834-2012·Announced 2012-06-27

Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance

Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors 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 foreign substance hazard that could be dislodged, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling the Sarns High-Flow Aortic Arch Cannula, 6.5 mm (20 Fr) 00 with 3/8" connector, 11" (28 cm) long, with XCoating surface coating. The device is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

The recall was initiated because Terumo CVS found a foreign substance on the outer surface of some cannulae connectors during production of one lot. A preliminary investigation determined that the substance can be dislodged from the cannula surface and was likely deposited during the molding process, though the exact composition of the particles was not fully specified in the provided text.

The recall affects 133,793 units distributed worldwide, including the United States and various international markets. Affected units are identified by Catalog number 12325X and Lot codes 558946, 0589263, 0603353, 0640527, and 0653443. Healthcare providers and facilities should check their inventory for these specific lot numbers and contact Terumo CVS for further instructions.

The recalled product

Product: SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG, WITH XCOATING SURFACE COATING. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Manufacturer: Terumo Cardiovascular Systems Corporation
Category: Medical Device — Surgical Cannula
Hazard: foreign-substance
contamination
Affected units: 133,793

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 (5)

Catalog number: 12325X and Lot codes: 558946
0589263
0603353
0640527
and 0653443.

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

Part of a larger recall action

This product is one of 11 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 11 products in this recall →

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Same hazard · foreign substance