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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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
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
See all →- HighCDI OneView System BPM Probe temperature sensor measurement inaccuracy
FDA (Devices) · 2025-07-02
- HighTerumo CDI OneView Monitor Probe May Fail to Display Oxygen Saturation Data
FDA (Devices) · 2025-04-09
- HighCardiovascular Procedure Kits Recalled for Pressure Relief Valve Defect
FDA (Devices) · 2024-04-10
- HighCAPIOX FX25 Oxygenator Recalled for Potential Leaks from Improper Bonding
FDA (Devices) · 2023-04-12
- HighTerumo Recalls CAPIOX NX19 Oxygenator Due to Improper Bonding
FDA (Devices) · 2023-04-12
Same hazard · battery malfunction
See all →- CriticalLife2000 Ventilation System battery charger defect causes device inoperability
FDA (Devices) · 2025-01-22
- SevereAmbulatory Infusion System Batteries May Short Circuit and Overheat
FDA (Devices) · 2024-11-06
- HighLIFEPAK 15 Defibrillators Recalled Due to Potential Loose Battery Pins
FDA (Devices) · 2023-11-22
- HighLIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Failure
FDA (Devices) · 2023-11-22
- HighLIFEPAK 15 Defibrillator Recalled for Loose Battery Pins Causing Power Loss
FDA (Devices) · 2023-11-22
Similar recalls
- SevereTerumo Sarns Centrifugal System Control Module Recalled for Power Loss
FDA (Devices) · 2012-10-17
- HighTerumo Sarns Modular Perfusion System 8000 Recalled for Power Malfunctions
FDA (Devices) · 2012-10-31
- HighTerumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions
FDA (Devices) · 2012-10-31
- HighTerumo Advanced Perfusion System 1 Recalled for Drive Motor Failure
FDA (Devices) · 2012-08-01
- SevereTerumo Sarns Modular Perfusion System 8000 Recalled for Monitor Malfunctions
FDA (Devices) · 2012-11-21
- HighTerumo Sarns Modular Perfusion System 9000 Recalled for Air Bubble Detection Malfunctions
FDA (Devices) · 2012-07-25