The Recall Desk
HighFDA (Devices)·Z-0461-2013·Announced 2012-12-12

Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect

Terumo is recalling Sarns Aortic Cannulas because plastic flash at the tip may detach and harm patients 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 is classified as FDA Class II. The hazard involves a potential defect (plastic flash detachment) that could cause adverse patient effects, but the source explicitly states that this failure has not been reported from the field as an observed defect, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling specific lots of the Sarns Soft-Flow Aortic Cannula. The recall involves 5,760 units of the 24 Fr 8mm Soft Flow Ang Wire W/L device, identified by catalog number 5762 and lot numbers 0570466 and 0589212. These devices are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery for up to 6 hours.

The recall was initiated because plastic flash was identified at the tip of certain lots. This plastic flash has the potential to detach and contribute to an adverse patient effect. Although this potential failure has not been reported from the field as an observed defect, the product was determined not to meet specifications, and the condition could result in an unacceptable risk.

The affected products were distributed worldwide, including in the United States (AL, CA, CO, DC, DE, FL, GA, IL, IN, KS, KY, LA, MA, MI, MO, MS, MT, NC, ND, NE, NH, NY, OH, PA, TN, TX, VA, and WI) and internationally to Australia, the United Arab Emirates, Singapore, Malaysia, Belgium, Japan, and Canada. Healthcare facilities should stop using the affected lots and contact Terumo for instructions on return or replacement.

The recalled product

Product
24 Fr 8mm Soft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Surgical Cannula
Hazard
Affected units
5,760

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)

  • catalog number: 5762 and lot number: 0570466 and 0589212

Distribution

Distributed in 27 states:

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

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