The Recall Desk
SevereFDA (Devices)·Z-0050-2013·Announced 2012-10-17

Terumo Sarns Centrifugal System Battery Backup Recall

Terumo CVS is recalling 289 Sarns Centrifugal System battery backups due to reported malfunctions that could cause unexpected loss of arterial flow.

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 recall is classified as FDA Class II and involves a medical device where malfunction could result in an unexpected loss of arterial flow, posing a significant risk of serious injury.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 289 units of the 220V battery backup system for the Sarns Centrifugal System. The recalled items include the battery, charger, and connecting cable. The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.

The recall is being conducted due to multiple reports received since 2004 of various malfunctions in the battery backup system. These reports are categorized as failure to charge, failure to hold charge, or failure to operate. In the most severe case, a battery malfunction could result in an unexpected loss of arterial flow.

The affected units were distributed worldwide, including in the United States and numerous international locations. The specific catalog number is 9491, and the affected lot numbers are 1001-1187, 1101, 1193-1286, 2083-2085, 2018, 2288, 2289, 2447-2451, 2634, 2635, and 2884. Users should contact Terumo Cardiovascular Systems Corporation for further instructions regarding the recall.

The recalled product

Product
Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Cardiopulmonary Bypass
Hazard
Affected units
289

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 (12)

  • Catalog number: 9491
  • and lot numbers: 1001-1187
  • 1101
  • 1193-1286
  • 2083-2085
  • 2018
  • 2288
  • 2289
  • 2447-2451
  • 2634
  • 2635
  • and 2884.

Distribution

Distributed in 43 states:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Terumo Cardiovascular Systems Corporation

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Same hazard · battery malfunction

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