Terumo Recalls Sarns Venous Return Cannulae Due to Exposed Wire
Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.
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 involves a structural defect (exposed wire) in a medical device used during surgery, which poses 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 without reported injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae. The affected devices are identified by Catalog Number 4936X. These medical devices are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery and are intended for up to 6 hours of use.
The recall was initiated after Terumo CVS identified exposed basket wire on certain product lots during in-process inspection. The source text does not specify the number of affected units, specific lot numbers, or the exact dates of manufacture or distribution.
The affected products were distributed worldwide, including in the United States (specifically CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, and TX) and internationally to 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 recalled product
- Product
- Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long, with X Coating 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…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
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 4936X
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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