Terumo Recalls Sarns Flexible Arterial Cannula Due to Foreign Substance
Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance found on the connector surface can be dislodged during use.
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 a foreign substance can be dislodged, representing a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling the Sarns Flexible Arterial Cannula, 8.0 mm (24 Fr) with 3/8" connector, suture ring, and 9.5" (24 cm) length. The recall affects 133,793 units distributed nationwide in the United States and in various countries worldwide.
The recall was initiated because Terumo CVS identified a foreign substance on the outer surface of some cannulae connectors during the production of one lot. A preliminary investigation determined that the substance was likely deposited during the molding process and can be dislodged from the cannula surface. The exact composition of the particles has not been fully determined in the provided text.
This product is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Healthcare facilities and distributors should stop using the affected units and contact Terumo CVS for further instructions. The affected catalog number is 13030, and the recall includes specific lot codes listed in the agency documentation.
The recalled product
- Product
- SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 133,793
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)
- Catalog number: 13030 and Lot code: 0553041
- 0555967
- 0557330
- 0559885
- 0562990
- 0564951
- 0567668
- 0570456
- 0571580
- 0575365
- 0580822
- 0583186
- 0585529
- 0590858
- 0593455
- 0596125
- 0600250
- 0605504
- 0609198
- 0614183
Distribution
Part of a larger recall action
This product is one of 11 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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