Datascope recalls Better Bladder device in custom tubing kits
Datascope is recalling the Better Bladder device in custom tubing kits because seal separation may allow air to enter the housing, potentially causing a drop in ECMO circuit blood 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 agency classified this as a Class II recall. The hazard involves a drop in ECMO circuit blood flow, which is a significant injury risk for patients on life support, fitting the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Datascope Corporation is recalling the BEQ-TOP 33500 3/8" ECC PACK (Catalog No. 701053752), which includes the Better Bladder device. The recall involves 3 units of Lot 3000056255. These products were distributed to accounts in Alabama, Arkansas, California, the District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas, and Washington.
The recall is due to a potential defect where seal separation from the housing may allow air to enter the housing and collapse the balloon. This issue may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
Healthcare facilities and consumers who have this product should stop using it and contact Datascope Corporation for further instructions.
The recalled product
- Product
- BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752
- Manufacturer
- Datascope Corporation
- Affected units
- 3
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)
- Lot 3000056255
Distribution
Part of a larger recall action
This product is one of 28 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 28 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 · air embolism
See all →- HighFARADRIVE STEERABLE SHEATH CLEAR Medical Device Recall
FDA (Devices) · 2026-07-29
- SevereBoston Scientific Steerable Sheath Recalled Due to Potential Air Embolism Risk
FDA (Devices) · 2026-07-29
- HighFARADRIVE Steerable Sheath Clear IDE Recall for Air Embolism Risk
FDA (Devices) · 2026-07-29
- HighBoston Scientific Steerable Sheath Recall Over Hemostatic Valve Damage
FDA (Devices) · 2026-07-29
- SevereMedical Angiographic Control Syringes Recalled for Rotating Adapter Risk
FDA (Devices) · 2026-05-20
Similar recalls
- LowDatascope Cardiopulmonary Bypass Tubing Kit Recalled for Cuvette Failure
FDA (Devices) · 2018-06-13
- LowDatascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits
FDA (Devices) · 2018-06-13
- HighBetter-Bladder ECMO Device May Collapse, Reducing Blood Flow
FDA (Devices) · 2021-06-23
- HighMaquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation
FDA (Devices) · 2019-06-05
- HighDatascope Small Patient ECC Pack Recalled for Excess Endotoxin
FDA (Devices) · 2016-06-22
- HighDatascope Recalls Maquet Cardiopulmonary Bypass Tubing Kits Due to Valve Defect
FDA (Devices) · 2018-06-20