Cardiosave Hybrid IABP Recalled for Potential Therapy Interruption at High Altitudes
Maquet Datascope is recalling Cardiosave Hybrid IABP devices due to a potential inability to start therapy for users at altitudes above 3,200 feet.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 agency classified this recall as Class I, which mandates a severity score of at least 4 according to the rubric.
Plain-English summary
Maquet Datascope Corp - Cardiac Assist Division is recalling the Cardiosave Hybrid IABP, Part Number 0998-00-0800-53. The recall is issued because there is a potential for interruption and/or inability to start therapy to the patient prior to or during use of the device for users who are at altitudes above 3,200 feet.
The affected devices were distributed US Nationwide and internationally to 77 countries. The recall includes all serial numbers associated with UDI 10607567108391. The agency has classified this recall as Class I.
Healthcare providers and users should contact the recalling firm for further instructions on how to manage the affected devices.
The recalled product
- Product
- Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
- Manufacturer
- Maquet Datascope Corp - Cardiac Assist Division
- Hazard
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 (1)
- UDI - 10607567108391 All Serial Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Maquet Datascope Corp - Cardiac Assist Division 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 · Maquet Datascope Corp - Cardiac Assist Division
See all →- SevereMaquet Cardiosave Rescue IABP Recalled for High Altitude Therapy Interruption
FDA (Devices) · 2018-11-07
- SevereMaquet Datascope Recalls CARDIOSAVE Hybrid Intra-Aortic Balloon Pumps
FDA (Devices) · 2018-06-06
- SevereMaquet CS 100 Intra-Aortic Balloon Pump Recalled for Electronic Defects
FDA (Devices) · 2017-09-13
- SevereMaquet CS 100i Intra-Aortic Balloon Pump Recalled for Fluid Ingress
FDA (Devices) · 2017-09-13
- SevereMaquet CS 300 Intra-Aortic Balloon Pump Recalled for Fluid Ingress Risk
FDA (Devices) · 2017-09-13
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- HighMaquet Recalls Cardiosave Hybrid and Rescue IABP Devices
FDA (Devices) · 2016-04-06
- SevereCardiosave Hybrid IABP Devices Recalled for Unexpected Shutdown Risk
FDA (Devices) · 2023-03-15
- SevereMaquet Datascope Recalls CARDIOSAVE Hybrid Intra-Aortic Balloon Pumps
FDA (Devices) · 2018-06-06
- HighDatascope Cardiosave Hybrid IABP Recalled for Cybersecurity Vulnerabilities
FDA (Devices) · 2021-05-05
- SevereCardiosave Hybrid IABP devices recalled for temperature and pumping function failures
FDA (Devices) · 2023-09-06
- HighMaquet CARDIOSAVE IABP Li-Ion Battery Recall Due to Venting Risk
FDA (Devices) · 2017-03-08