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 medical device with a physical defect (exposed wire) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
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 indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. The specific product involved is the 34/46 Fr model with a 1/2" connector and 15" (38 cm) length, identified by Catalog Number 4936.
The recall was initiated after Terumo CVS identified exposed basket wire on certain product lots during in-process inspection. This defect presents a potential risk of injury to patients during the use of the device.
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 users should stop using the affected lots and contact Terumo CVS for further instructions.
The recalled product
- Product
- Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long 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…
- 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 4936
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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