Datascope Cardiosave Hybrid Intra-Aortic Balloon Pump Recalled for Labeling Defects
Datascope Corp. is recalling 6,197 Cardiosave Hybrid Intra-Aortic Balloon Pumps worldwide due to inadequate labeling regarding battery maintenance.
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 source text explicitly identifies the agency classification as Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must never go below 4.
Plain-English summary
Datascope Corp. is recalling 6,197 units of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), model 0998-00-0800-53, for cardiovascular use. The recall is classified as Class I by the U.S. Food and Drug Administration. The devices were distributed worldwide, including in the United States and numerous international locations.
The recall is initiated due to inadequate labeling. The source text notes that battery short-run times and unanticipated stoppage may be due to users not performing necessary battery maintenance and handling. The recall specifically targets the labeling issues, while design updates are planned for a subsequent recall.
Healthcare providers and users should stop using the affected devices and contact Datascope Corp. for further instructions. All serial numbers are affected.
The recalled product
- Product
- Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.
- Manufacturer
- Datascope Corp.
- Category
- Medical Device — Cardiovascular
- Affected units
- 6,197
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)
- All serial numbers affected
Distribution
Part of a larger recall action
This product is one of 6 recalled by Datascope Corp. 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 6 products in this recall →Related recalls
Same manufacturer · Datascope Corp.
See all →- ModerateCardiosave battery charging station left bay screw prevents full battery insertion
FDA (Devices) · 2026-03-25
- ModerateDatascope CS100 balloon pump manual recalled for outdated battery specifications
FDA (Devices) · 2026-03-11
- ModerateDatascope CS300 balloon pump manual recalled for outdated battery specifications
FDA (Devices) · 2026-03-11
- LowBalloon pump instructions updated to reference the correct vibration standards
FDA (Devices) · 2025-12-24
- LowRescue balloon pump instructions updated to reference the correct vibration standards
FDA (Devices) · 2025-12-24
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02