The Recall Desk
HighFDA (Devices)·Z-1876-2012·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 can 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 is classified as FDA Class II. The hazard involves a dislodgable foreign substance in a medical device used during cardiac surgery, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling the Sarns Antegrade Cardioplegia Cannula, Root Infusion Vent/Catheter with 14-gauge white needle, rectangular flange, 6" (15 cm) long. The recall involves 53,139 units distributed worldwide, including nationwide in the United States and in various international countries.

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

The product is indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Affected catalog number is 203887, and specific lot numbers are listed in the recall documentation.

The recalled product

Product
SARNS ANTEGRADE: CARDIOPLEGIA CANNULA: ROOT INFUSION VENT/CATHETER WITH 14- GAUGE WHITE NEEDLE, RECTANGULAR FLANGE, 6" (15 CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardiopl
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 (20)

  • Catalog number: 203887 and lot numbers: 0551678
  • 0557083
  • 0561754
  • 0562984
  • 0568008
  • 0572137
  • 0575072
  • 0580833
  • 0583190
  • 0586161
  • 0591033
  • 0596204
  • 0605323
  • 0612587
  • 0615536
  • 0619196
  • 0622171
  • 0627245
  • 0631928
  • 0632342

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 →

Related recalls

Same manufacturer · Terumo Cardiovascular Systems Corporation

See all →

Same hazard · foreign substance

See all →