Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 54,816 kits distributed worldwide.
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 3/5 (High).
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: The recall is classified as FDA Class II and involves a high-risk pathogen (endotoxin) without reported illnesses or injuries in the source text, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Datascope Corporation is recalling specific lots of Intra-Aortic Balloon Catheters (IABs) Linear 7.5Fr 34cc IAB Kits. The recall is being conducted because of potential endotoxin contamination in the product. The affected product is indicated for use in acute coronary syndrome, cardiac and non-cardiac surgery, and complications of heart failure.
The recall covers 54,816 kits that were distributed worldwide, including nationwide distribution in the United States and in numerous other countries. The specific lot numbers affected are listed in the official recall documentation. The agency has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and facilities should stop using the affected lots of Intra-Aortic Balloon Catheters immediately. Users should check their inventory against the list of affected lot numbers provided by the manufacturer. If the product is found in inventory, it should be quarantined and returned to Datascope Corporation in accordance with their instructions.
The recalled product
- Product
- Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0684-00-0479-02U, 0684-00-0479-07, 0684-00-0479-08, 0684-00-0479-10 - Product Usage: Indications For Use: Acute Coronary Syndrome…
- Manufacturer
- Datascope Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 54,816
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Datascope 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 17 products in this recall →Related recalls
Same manufacturer · Datascope Corporation
See all →- HighLINEAR Intra-Aortic Balloon Catheter Recalled for Incorrect Volume Labeling
FDA (Devices) · 2022-11-02
- HighMEGA Intra-Aortic Balloon Catheter Recalled for Undersized Dilator
FDA (Devices) · 2022-09-14
- HighUndersized Dilator in Balloon Catheter Insertion Kit Recalled
FDA (Devices) · 2022-09-14
- HighFDA Recalls Sensation Plus Catheter for Undersized Dilator Manufacturing Defect
FDA (Devices) · 2022-09-14
- HighDatascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
FDA (Devices) · 2020-09-02
Same hazard · endotoxin contamination
See all →- HighMedline Medical Convenience Kits Recalled for Endotoxin Levels
FDA (Devices) · 2026-09-02
- HighCardinal Health Presource Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-08-19
- HighCardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges
FDA (Devices) · 2026-08-19
- HighNeurological Sponges Recalled Due to Potential Variability in Endotoxin Levels
FDA (Devices) · 2026-08-05
- HighMedline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin
FDA (Devices) · 2026-05-06
Similar recalls
- CriticalIntra-Aortic Balloon Catheter kits recalled due to dilator fracture risk
FDA (Devices) · 2023-08-02
- CriticalLINEAR intra-aortic balloon catheter introducer dilator fracture risk
FDA (Devices) · 2023-08-02
- ModerateDatascope Mega Intra-Aortic Balloon Catheter Recalled for Missing Contraindications
FDA (Devices) · 2018-04-25
- LowDatascope Recalls Linear Intra-Aortic Balloon Catheter for Labeling Error
FDA (Devices) · 2014-09-10
- HighLINEAR Intra-Aortic Balloon Catheter Recalled for Incorrect Volume Labeling
FDA (Devices) · 2022-11-02
- ModerateDatascope Intra-Aortic Balloon Catheter Recalled for Reversed Date Labels
FDA (Devices) · 2019-07-24