Agency classClass IIOur severity:Severe FDA (Devices)·Z-1715-2018·Announced 2018-05-16

Datascope recalls Better Bladder device due to seal separation risk

Datascope is recalling the Better Bladder device because seal separation may cause balloon collapse and reduced 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 extracorporeal membrane oxygenation (ECMO) that could 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 Better Bladder device, which is provided as part of some custom tubing kits. The specific product is the BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295. A total of 9 units are affected, with lot numbers 3000057379, 3000063707, and 3000066885.

The recall is due to a potential seal separation from the housing. This defect may allow air to enter the housing, causing the balloon to collapse. Such a collapse may increase resistance to flow in the venous line and cause a drop in blood flow within the ECMO circuit.

The affected 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 providers and facilities should stop using the affected devices and contact the manufacturer for further instructions.

The recalled product

Product: BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295
Manufacturer: Datascope Corporation
Category: Medical Device — Cardiovascular / ECMO
Hazard: structural-defect
blood-flow-reduction
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 (3)

Lot 3000057379
3000063707
3000066885

Distribution

Distributed in 13 states:

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.

See all 28 products in this recall →

Same manufacturer · Datascope Corporation

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Same hazard · structural defect