The Recall Desk
HighFDA (Devices)·Z-0670-2013·Announced 2013-01-23

Terumo Recalls Sarns High-Flow Aortic Arch Cannulas Due to Connector Flash

Terumo is recalling Sarns High-Flow Aortic Arch Cannulas and Flexible Arterial Cannulae because connector flash may detach during surgery.

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 medical device with a risk of harm (detachment of material in the operative field) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling Sarns High-Flow Aortic Arch Cannulas and Sarns Flexible Arterial Cannulae. The recall involves 6,830 units of the 6.5 mm (20 Fr) OD cannula with a 3/8in connector, 11in (28 cm) long, manufactured with lot numbers 0680122 and 0680751 and catalog number 12325.

The recall was initiated because the connectors were found to contain flash on the exterior that exceeded established specifications. This flash has the potential to detach in the operative field during cardiopulmonary bypass surgery.

The affected products were distributed nationwide and worldwide, including in the United States, Canada, Brazil, and several other countries. Healthcare facilities and users should stop using the affected lots and contact Terumo Cardiovascular Systems Corporation for further instructions.

The recalled product

Product
Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are i
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Surgical Cannula
Hazard
Affected units
6,830

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 (2)

  • Lot number: 0680122
  • 0680751and Catalog number: 12325

Distribution

Distributed nationwide across the United States.

The notice also names 32 states specifically:

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

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