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 is classified as FDA Class II, and the hazard involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling specific lots of Sarns Soft-Flow Aortic Cannulas. The recall involves 5,760 units of the 18 Fr 6mm Sft Flow Angled Wire, which are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
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 devices were distributed worldwide, including in the United States and internationally to Australia, the United Arab Emirates, Singapore, Malaysia, Belgium, Japan, and Canada. The specific catalog number is 7071, and the affected lot numbers are 0597322, 0602541, 0610241, 0615610, 0619197, 0620809, and 0620810. Users should check their inventory for these specific lot numbers and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 18 Fr 6mm Sft Flow Angled Wire 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 (7)
- catalog number: 7071 and lot number: 0597322
- 0602541
- 0610241
- 0615610
- 0619197
- 0620809
- and 0620810.
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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