Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse
Datascope is recalling 18 custom tubing kits because a seal defect may cause the Better Bladder 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 defect that may cause a drop in blood flow in ECMO circuits, posing a significant risk of injury to patients.
Plain-English summary
Datascope Corporation is recalling 18 units of the BEQ-TOP 41201 ECC 3/8 PUMP PAC Custom Tubing Kit, Catalog No. 701064867. The affected lots are 3000057376 and 3000063289. These kits 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. A seal separation from the housing may allow air to enter, causing the balloon to collapse. This collapse may increase resistance to flow in the venous line and cause a drop in blood flow within the ECMO circuit.
Healthcare facilities and distributors should stop using the affected kits and contact Datascope Corporation for further instructions on the recall.
The recalled product
- Product
- BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
- Manufacturer
- Datascope Corporation
- Affected units
- 18
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 3000057376
- 3000063289
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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