Datascope Better Bladder Device Recalled Due to Seal Separation Risk
Datascope Corporation is recalling the Better Bladder device found in custom tubing kits. A seal defect may allow air entry, causing balloon collapse and reduced blood flow in ECMO circuits.
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 used in ECMO circuits where a defect could cause a drop in blood flow, representing a significant risk of serious injury.
Plain-English summary
Datascope Corporation is recalling the Better Bladder device, which is provided as part of some custom tubing kits. The specific product affected is the BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179, Lot 3000058051.
The recall is due to a potential seal separation from the housing. This defect may allow air to enter the housing and cause the balloon to collapse. Such a collapse may increase resistance to flow in the venous line and cause a drop in blood flow within the ECMO circuit.
The affected devices were distributed to accounts in Alabama, Arkansas, California, the District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas, and Washington. Healthcare facilities and users of these custom tubing kits should stop using the affected devices and contact the manufacturer for instructions on replacement or return.
The recalled product
- Product
- BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179
- Manufacturer
- Datascope Corporation
- Affected units
- 1
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 3000058051
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.
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