The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0456-2013·Announced 2012-12-12

Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect

Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 cause adverse patient effects, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 5,760 units of Sarns Soft-Flow Aortic Cannulas (catalog numbers 5841 and 5845, lot numbers 0581536 and 0581138). The recall was initiated because plastic flash was identified at the tip of certain lots of the device.

The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery, with a maximum indicated use of up to 6 hours. The identified plastic flash has the potential to detach and contribute to an adverse patient effect. While this specific failure has not been reported from the field as an observed defect, the manufacturer determined that the product does not meet specifications and the condition could result in an unacceptable risk.

The affected devices 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 further instructions.

The recalled product

Product
24 Fr 8mm Sft Flow Str 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: 5841 and 5845 and lot number: 0581536 and 0581138.

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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