Terumo Recalls Sarns Dual-stage Venous Return Cannulae Due to Exposed Wire
Terumo CVS is recalling Sarns Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.
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 structural defect (exposed wire) in a medical device used during surgery, which presents a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling Sarns Dual-stage Venous Return Cannulae and Sarns Malleable Dual-stage Venous Return Cannulae. The recall was initiated after in-process inspections identified exposed basket wire on certain product lots. These devices are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery.
The affected products are identified by Catalog Number 16473. The distribution pattern includes the United States (specifically CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, and TX) and international markets including the United Arab Emirates, Taiwan, Thailand, Malaysia, Belgium, Japan, Mexico, and Canada.
Healthcare facilities and distributors should stop using the affected devices and contact Terumo CVS for instructions on return or replacement. The source text does not specify the number of affected units or report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- Sarns Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass s
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
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 16473
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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