Terumo Recalls Sarns Flexible Arterial Cannulas Due to Foreign Substance
Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance was found on the connectors that can be dislodged.
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, 7.3 mm (22 Fr) 00 with 3/8" connector, suture ring, and 9.5" (24 cm) length. The product is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. The recall involves 133,793 units distributed nationwide in the United States and in 21 countries worldwide.
The recall was initiated after Terumo CVS found a foreign substance on the outer surface of some cannulae connectors during the production of one lot. A preliminary investigation determined that the substance can be dislodged from the cannula surface and was likely deposited during the molding process. The exact composition of the particles was not specified in the source text.
Healthcare providers and facilities that have received these products should stop using them and contact Terumo CVS for further instructions. The specific lot codes and catalog number are listed in the structured product information.
The recalled product
- Product
- SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 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: 13020 and Lot codes: 0550552
- 0555854
- 0557327
- 0559103
- 0562503
- 0566861
- 0570455
- 0574279
- 0577885
- 0581606
- 0585963
- 0590856
- 0593457
- 0597308
- 0605179
- 0609199
- 0614248
- 0618969
- 0626379
- 0628950
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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