Datascope recalls custom tubing kits with potential Better Bladder seal defect
Datascope is recalling nine custom tubing kits because a seal defect in the Better Bladder device may allow air entry, 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 nine units of the BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368, Lot 3000060487. The recall involves the Better Bladder device included in these kits.
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.
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. Healthcare facilities and users should stop using the affected kits and contact Datascope Corporation for further instructions.
The recalled product
- Product
- BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368
- Manufacturer
- Datascope Corporation
- Affected units
- 9
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 3000060487
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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