Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect
Terumo is recalling Sarns Aortic Cannulas because plastic flash at the tip could 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 involves a high-risk medical device where a defect could result in harm to patients, but the source explicitly states that the 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 5,760 units of the 24 Fr 8mm Sft Flow Straight Sarns Aortic Cannula. The recall involves catalog number 5847 and lot numbers 0582251 and 0586068. 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. The company determined that the product does not meet specifications and that this condition could result in an unacceptable risk, although this specific failure has not been reported from the field as an observed defect.
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 further instructions.
The recalled product
- Product
- 24 Fr 8mm Sft Flow Straight 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
- 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: 5847 and lot number: 0582251 and 0586068
Distribution
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.
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