The Recall Desk
HighFDA (Devices)·Z-0668-2013·Announced 2013-01-23

Terumo Sarns Arterial Cannulas Recalled for Connector Flash Defect

Terumo is recalling Sarns flexible arterial and high-flow aortic arch cannulas because exterior flash on the connectors 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 defect that could lead to injury (detachment of material in the operative field), but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling Sarns flexible arterial cannulas and high-flow aortic arch cannulas. The recall affects 6,830 units of the 8.0 mm (24 Fr) flexible arterial cannula with 3/8in connector, suture ring, and 9.5in length. The affected lots are 0677287 and 0681074, with catalog number 13030.

The recall was initiated because the connectors were identified 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 products were distributed nationwide and worldwide, including to specific US states and international locations such as Canada, Brazil, and the UAE.

Healthcare facilities and distributors should stop using the affected cannulas and contact Terumo Cardiovascular Systems Corporation for further instructions. No specific illnesses or injuries are reported in the source text, but the defect poses a risk of foreign material detachment during surgery.

The recalled product

Product
Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannula
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Surgical Cannulas
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 (1)

  • Lot number: 0677287 and 0681074 and Catalog number: 13030

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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Same manufacturer · Terumo Cardiovascular Systems Corporation

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