Datascope recalls Better Bladder device due to seal separation risk
Datascope is recalling the Better Bladder device because seal separation may allow air to enter the housing, potentially collapsing the balloon and reducing ECMO 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 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, part of custom tubing kits, due to a potential seal separation issue. The affected device is identified by Catalog No. 701050790 and includes units from Lot 3000060359 and 3000062725.
The recall was initiated because seal separation from the housing may allow air to enter the housing and collapse the balloon. This malfunction may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
A total of 4 units 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 consumers should stop using the affected devices and contact Datascope Corporation for further instructions.
The recalled product
- Product
- BEQ-TOP 22701, Catalog No. 701050790
- Manufacturer
- Datascope Corporation
- Affected units
- 4
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 (2)
- Lot 3000060359
- 3000062725
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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