The Recall Desk
HighFDA (Devices)·Z-0667-2013·Announced 2013-01-23

Terumo Recalls Sarns Flexible Arterial Cannulas Due to Connector Flash

Terumo Cardiovascular Systems is recalling Sarns flexible arterial cannulas and high-flow aortic arch cannulas because the connectors contain flash that 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 flash in the operative field) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling Sarns flexible arterial cannulas and Sarns high-flow aortic arch cannulas. The affected products are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

The recall was initiated because the connectors on these devices were identified to contain flash on the exterior that exceeded established specifications. This flash has the potential to detach in the operative field.

The recall affects 6,830 units of the Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long. The specific lot number is 0677284 and the catalog number is 13020. The products were distributed nationwide and worldwide, including to specific U.S. states and international locations such as Bahrain, Brazil, Canada, Chile, Honduras, Singapore, Taiwan, Trinidad and Tobago, and the United Arab Emirates.

The recalled product

Product
Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cann
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: 0677284 and Catalog number: 13020

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 →