Terumo Recalls Sarns Venoatrial Cannulae Due to Loose Fiber Particulate
Terumo CVS is recalling 3,040 Sarns Venoatrial Cannulae units because in-process inspections found loose fiber particulate exceeding specifications.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 3,040 units of Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector. The recall affects specific part numbers and lots, including Part No. 4440 and Part No. 164525, as detailed in the structured product information.
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 and venous drainage during cardiopulmonary bypass surgery.
The affected units were distributed worldwide, including nationwide in the United States and in several international countries. The source text does not report any illnesses or injuries associated with this recall. Healthcare providers and facilities should check their inventory for the affected part numbers and lot numbers and stop using these devices.
The recalled product
- Product
- Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector 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. The Venous Return Cannula…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 3,040
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 (16)
- Part No. 4440
- Lot #: 0646496
- 0650492
- 0659856
- 0666657
- 0674751
- 0677190
- 0686887
- 0690546
- Part No. 164525
- Lot #: 0646401
- 0652209
- 0656640
- 0662516
- 0674459
- 0678212
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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Similar recalls
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