[pending] Cardiosave Hybrid
Pending LLM rewrite. Source: FDA_DEVICE Z-0931-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
The recalled product
- Product
- Cardiosave Hybrid
- Manufacturer
- Datascope Corp.
- Category
- Medical Device — Devices
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)
- 1) Model: 0998-00-0800-31
- UDI-DI: 10607567109053
- Serial Numbers: All
- 2) Model: 0998-00-0800-32
- UDI-DI: 10607567111117
- 3) Model: 0998-00-0800-33
- UDI-DI: 10607567109008
- 4)Model: 0998-00-0800-35
- UDI-DI: 10607567109107
- 5)Model: 0998-00-0800-36
- UDI-DI: 10607567114187
- 6)Model: 0998-00-0800-45
- UDI-DI: 10607567108421
- 7)Model: 0998-00-0800-52
- UDI-DI: 10607567108438
- 8)Model: 0998-00-0800-53
- UDI-DI: 10607567108391
- 9) Model: 0998-00-0800-55
- UDI-DI: 10607567108414
- 10) Model: 0998-00-0800-65
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModeratePhilips Allura X-ray Systems Deaeration Hose Degradation Recall
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
- HighTangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27