The Recall Desk
HighFDA (Devices)·Z-1875-2012·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 found on the inner surface of some tips can be dislodged during use.

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 foreign substance that can be dislodged and introduced into the patient's body during a surgical procedure. This presents a risk of harm (High) as the substance enters the bloodstream, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling Sarns Antegrade Cardioplegia Cannulas, specifically the Root Infusion Vent Catheter with 12 Gauge Blue Needle Rectangular Flange, 6" (15 cm) long. The recall involves 53,139 units distributed worldwide, including nationwide distribution in the United States and in various countries such as Belgium, Brazil, Japan, and Mexico.

During production, Terumo CVS identified the presence of a foreign substance on the inner surface of some cannula tips. A preliminary investigation determined 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.

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 units can be identified by catalog number 203861 and specific lot numbers listed in the recall documentation. Healthcare facilities and distributors should stop using the affected devices and contact Terumo CVS for instructions on return or replacement.

The recalled product

Product
Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE 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 cardioplegi
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: 203861: 0548731
  • 0552411
  • 0556018
  • 0558941
  • 0563005
  • 0565138
  • 0565841
  • 0569745
  • 0570058
  • 0571163
  • 0571584
  • 0573043
  • 0573288
  • 0575518
  • 0580832
  • 0583446
  • 0585251
  • 0586160
  • 0590448
  • 0591942

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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