Datascope recalls Better Bladder device in custom tubing kits
Datascope is recalling 11 custom tubing kits containing the Better Bladder device due to a seal defect that may cause balloon collapse and reduced 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 recall is classified as FDA Class II and involves a medical device defect that may cause a drop in ECMO circuit blood flow, which constitutes a significant injury risk.
Plain-English summary
Datascope Corporation is recalling 11 units of the BO-TOP 13901 RAPID RESPONSE Custom Tubing Kit, Catalog No. 701054874. The recall involves the Better Bladder device provided as part of these kits.
The recall was initiated because seal separation from the housing may allow air to enter the housing and collapse the balloon. This defect may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
The affected 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 specific lot number is 3000067221. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled units.
The recalled product
- Product
- BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
- Manufacturer
- Datascope Corporation
- Affected units
- 11
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 3000067221
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 · 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 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
- LowDatascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits
FDA (Devices) · 2018-06-13
- HighDatascope Recalls Maquet Cardiopulmonary Bypass Tubing Kits Due to Valve Defect
FDA (Devices) · 2018-06-20
- SevereCirculatory Technology Recalls Better-Bladder ECMO Blood Reservoirs
FDA (Devices) · 2018-03-07
- LowDatascope Cardiopulmonary Bypass Tubing Kit Recalled for Cuvette Failure
FDA (Devices) · 2018-06-13
- HighBetter-Bladder ECMO Device May Collapse, Reducing Blood Flow
FDA (Devices) · 2021-06-23
- HighCirculatory Technology Recalls Bigger-Better-Bladder Medical Devices Due to Seal Leak
FDA (Devices) · 2016-07-06