Terumo Recalls Sarns Soft-Flow Aortic Cannulae Due to Fiber Particulate
Terumo CVS is recalling Sarns Soft-Flow Aortic Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
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 used in surgery where particulate contamination poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling Sarns Soft-Flow Extended Aortic Cannulae (7.0mm and 8.0mm) with or without luer and Xcoating. The recall involves 135,340 units distributed worldwide, including the United States and several international markets.
The recall was initiated after an in-process inspection identified the presence of loose fiber particulate that exceeded finished product specifications. These devices are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery for up to 6 hours.
The source text does not specify reported illnesses or injuries. Users should contact Terumo Cardiovascular Systems Corporation for further instructions regarding the affected lots and part numbers.
The recalled product
- Product
- Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The 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
- 135,340
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 (20)
- Part No. 4948
- Lot #: 0646471
- 0652314
- 0652909
- 0656645
- 0658692
- 0662071
- 0666665
- 0669799
- 0672089
- 0675750
- 0676585
- 0678728
- 0681792
- 0684780
- 0685667
- 0688001
- 0691202
- 0693823
- 0694711
Distribution
Part of a larger recall action
This product is one of 13 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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