Agency classClass IIOur severity:Severe FDA (Devices)·Z-1713-2018·Announced 2018-05-16

Datascope Recalls Better Bladder Device in Custom Tubing Kits

Datascope is recalling the Better Bladder device in custom tubing kits because seal separation may cause balloon collapse and reduced blood flow.

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 structural defect in a medical device used for ECMO that could cause a drop in blood flow, meeting the criteria for a Severe rating.

Plain-English summary

Datascope Corporation is recalling the Better Bladder device, which is provided as part of some custom tubing kits. The specific product affected is the BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486, Lot 3000061302. Ten 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.

The recall was initiated because seal separation from the housing may allow air to enter the housing and collapse the balloon. This failure may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.

The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units, nor does it report any injuries or illnesses associated with the defect.

The recalled product

Product: BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486
Manufacturer: Datascope Corporation
Category: Medical Device — ECMO Components
Hazard: structural-defect
reduced-blood-flow
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 3000061302

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