The Recall Desk
HighFDA (Devices)·Z-1877-2012·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.

What this means for you

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 risk of harm (foreign substance dislodgement) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling Sarns Antegrade Cardioplegia Cannulas, specifically the Root Infusion Cannula with 14-gauge white needle, rectangular flange, and suture collar. The recall involves 53,139 units distributed nationwide in the United States and in various countries worldwide, including Belgium, Brazil, Japan, and Mexico.

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

These devices are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, vent the left heart, and aspirate air from the aorta during cardiopulmonary bypass procedures. Affected catalog number 203895 units include specific lot numbers listed in the recall documentation. Users should stop using the affected devices and contact the manufacturer for further instructions.

The recalled product

Product
SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE 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 — Cardiovascular
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 (20)

  • Catalog number: 203895 and lot numbers: 0551294
  • 0555085
  • 0557607
  • 0560171
  • 0563852
  • 0568020
  • 0572133
  • 0579089
  • 0586166
  • 0592735
  • 0598461
  • 0603720
  • 0611573
  • 0616893
  • 0619181
  • 0625003
  • 0633298
  • 0637811
  • 0640423
  • 0645344

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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