The Recall Desk
HighFDA (Devices)·Z-0666-2013·Announced 2013-01-23

Terumo Recalls Sarns Arterial Cannulas Due to Connector Flash

Terumo is recalling Sarns flexible arterial cannulas and high-flow aortic arch cannulas 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 risk-of-harm product where the flash has the potential to detach in the operative field, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling Sarns flexible arterial cannulas and high-flow aortic arch cannulas. The recall involves 6,830 total units of these medical devices, which are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

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

The affected products were distributed nationwide and worldwide to various states and countries, including Bahrain, Brazil, Canada, Chile, Honduras, Singapore, Taiwan, Trinidad and Tobago, and the United Arab Emirates. The specific lot number is 0677286 and the catalog number is 13010. Healthcare facilities should stop using these devices and contact the manufacturer for instructions on return or disposal.

The recalled product

Product
Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Ca
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 (1)

  • Lot number: 0677286 and Catalog number: 13010.

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 →

Related recalls

Same manufacturer · Terumo Cardiovascular Systems Corporation

See all →

Same hazard · foreign object detachment

See all →