Datascope recalls Better Bladder device in custom tubing kits
Datascope is recalling the Better Bladder device in some custom tubing kits because seal separation may cause the balloon to collapse, potentially reducing 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 defect that could cause a drop in ECMO circuit blood flow, posing 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 recall is due to a defect where 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 blood flow in the ECMO circuit. The affected product is the Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513, specifically Lot 3000060036.
The product was distributed to accounts in Alabama, Arkansas, California, the District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas, and Washington. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled items.
The recalled product
- Product
- Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513
- 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 3000060036
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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