The Recall Desk
HighFDA (Devices)·Z-1833-2012·Announced 2012-06-27

Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance

Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors 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 involves a medical device with a foreign substance that can be dislodged, posing a risk of harm during surgery, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling the Sarns High-Flow Aortic Arch Cannula, 6.5 mm (20 Fr) 00 with 3/8" connector, 11" (28 cm) long. The device is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. The recall affects 133,793 units distributed nationwide in the United States and in various countries worldwide.

The recall was initiated because 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 provided source text.

Healthcare providers and facilities should stop using the affected devices 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 HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 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
Category
Medical Device — Surgical Cannula
Hazard
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: 12325 and Lot codes: 0551680
  • 0553010
  • 0557571
  • 0559882
  • 0562967
  • 0566831
  • 0569995
  • 0575870
  • 0579316
  • 0584969
  • 0589928
  • 0593454
  • 0595251
  • 0601331
  • 0606816
  • 0611597
  • 0617494
  • 0622167
  • 0626795
  • 0629156

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

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.

See all 11 products in this recall →

Related recalls

Same manufacturer · Terumo Cardiovascular Systems Corporation

See all →

Same hazard · foreign substance

See all →