The Recall Desk
SevereFDA (Devices)·Z-1883-2012·Announced 2012-07-04

Terumo Recalls Sarns Antegrade Cardioplegia Cannula Due to Foreign Substance

Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance on the inner surface of some tips can be dislodged.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects in medical devices, are categorized as Severe (Score 4).

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling the Sarns Antegrade Cardioplegia Cannula, specifically the X-Coated Small Patient Pack. The recall affects 53,139 units distributed worldwide, including nationwide in the United States and in various countries such as Belgium, Brazil, Japan, and Mexico. The affected products are identified by catalog number 71936-01 and lot numbers MH06, ML20, MN15, NG20, and NG20A.

The recall was initiated after Terumo CVS identified the presence of 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. The FDA has classified this as a Class II recall. Healthcare providers and facilities should stop using the affected devices and contact Terumo CVS for further instructions.

The recalled product

Product
X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are 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 c
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 (5)

  • Catalog number: 71936-01 and lot number: MH06
  • ML20
  • MN15
  • NG20
  • and NG20A.

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 →