Terumo Recalls Sarns Venous Return Cannulae Due to Loose Fiber Particulate
Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae 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 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 high-risk medical device used in surgery where the presence of particulate matter poses a risk of harm, but the source text does not report any specific 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 (28/38, 32/40 & 34/46 Fr) with 1/2" connectors, with or without Xcoating. The recall involves 7,190 units distributed worldwide, including the United States and several international markets.
The recall was initiated after an in-process inspection identified the presence of loose fiber particulate that exceeded finished product specifications. The product is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
Healthcare facilities and distributors should stop using the affected lots and contact Terumo CVS for instructions on return or replacement. The specific part numbers and lot numbers affected are listed in the official recall documentation.
The recalled product
- Product
- Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 7,190
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. 4934
- Lot #: 0655207
- 0657317
- 0666535
- 0682313
- 0697852
- Part No. 4934X
- Lot #: 0659445
- 0696672
- Part No. 4935
- Lot #: 0655206
- 0656923
- 0682315
- 0685669
- 0696718
- Part No. 4936
- Lot #: 0655292
- 0665320
- 0684443
- 0684444
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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