The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1878-2012·Announced 2012-07-04

Terumo Recalls Sarns Antegrade Cardioplegia Cannulas Due to Foreign Substance

Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some tips that could 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 is classified as FDA Class II, and the hazard involves a dislodgable foreign substance in a medical device used in cardiac surgery, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling Sarns Antegrade Cardioplegia Cannulas. The recall involves 53,139 units distributed worldwide, including the United States and various international locations. The affected product is indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart during cardiopulmonary bypass procedures.

During production, Terumo CVS identified the presence of a foreign substance on the inner surface of some cannula tips. A preliminary investigation found that this substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, though the exact composition is not specified in the source text.

The recall includes catalog number 203879 and specific lot numbers: 0558280, 0574328, 0590421, 0607092, 0613016, 0627693, 0641300, 0653436, 0655320, and 0666687. Healthcare providers and facilities should check their inventory for these specific catalog and lot numbers and stop using the affected devices.

The recalled product

Product
SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 12-GAUGE BLUE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver…
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Cardiac Surgery
Hazard
Affected units
53,139

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 (10)

  • Catalog number: 203879 and lot numbers: 0558280
  • 0574328
  • 0590421
  • 0607092
  • 0613016
  • 0627693
  • 0641300
  • 0653436
  • 0655320
  • and 0666687.

Distribution

Distributed nationwide across the United States.

The notice also names 29 states specifically:

Part of a larger recall action

This product is one of 20 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.

See all 20 products in this recall →

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