Terumo Dual-stage Venous Return Cannulae Recalled for Loose Fiber Particulate
Terumo CVS is recalling specific lots of venous return cannulae used in heart surgery due to loose fiber particulate found during inspection.
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, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 34,470 units of Terumo Dual-stage Venous Return Cannulae. The recall affects specific sizes (28/38, 29/37, 32/40, 34/46, 36/46, and 36/51 Fr) with 1/2" flare or connector, manufactured by Terumo CVS. These devices are indicated for venous drainage during cardiopulmonary bypass surgery.
The recall was initiated after an in-process inspection identified the presence of loose fiber particulate that exceeded finished product specifications. The affected products were distributed worldwide, including nationwide in the United States and in several other countries such as Australia, Canada, and the United Kingdom.
Healthcare providers and facilities should check their inventory for the specific part numbers and lot numbers listed in the official recall notice. If the affected devices are found, they should be removed from service and returned to Terumo CVS according to the company's instructions.
The recalled product
- Product
- Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 34,470
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. 813580
- Lot #: AM004245
- AM006060
- AM016524
- Part No. 813579
- Lot #: AM001313
- AM007311
- AM007721
- AM009067
- AM016176
- AM016523
- AM018165
- Part No. 813582
- Lot #: AM001293
- AM017320
- Part No. 813581
- Lot #: AM002694
- AM003543
- AM006059
- AM017959
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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