Datascope Recalls Better Bladder Devices in Custom Tubing Kits
Datascope is recalling specific custom tubing kits because the Better Bladder device may fail, 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 involves a structural defect in a medical device used for 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 the BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01. The recall involves four units from Lot 3000059724. These 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.
The recall is due to a defect in the Better Bladder device included in the kits. Seal separation from the housing may allow air to enter the housing, causing the balloon to collapse. This failure may increase resistance to flow in the venous line and cause a drop in blood flow within the ECMO circuit.
Healthcare facilities and accounts that received these specific kits should stop using the affected Better Bladder devices and contact Datascope Corporation for instructions on how to return or replace the products.
The recalled product
- Product
- BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01
- 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 (1)
- Lot 3000059724
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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