Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse
Datascope is recalling 10 custom tubing kits because a seal defect may allow air to enter the housing, causing the balloon to collapse and 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 defect in a life-support device (ECMO) that can cause a drop in blood flow, meeting the criteria for a Severe rating due to significant injury risk.
Plain-English summary
Datascope Corporation is recalling 10 units of the BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit (Catalog No. 701066949R02, Lot 3000060844). The recall involves the Better Bladder device included in these kits.
The recall is due to a potential seal separation from the housing. This defect may allow air to enter the housing, which can cause the balloon to collapse. If the balloon collapses, it may increase resistance to flow in the venous line and cause a drop in blood flow within the ECMO circuit.
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 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02
- Manufacturer
- Datascope Corporation
- Affected units
- 10
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 3000060844
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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