Datascope Corporation: Medical Device Recall in 2018 - (Recall #: Z-1720-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02

Product Classification:

Class II

Date Initiated: October 19, 2017

Date Posted: May 16, 2018

Recall Number: Z-1720-2018

Event ID: 79873

Reason for Recall:

The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.

Status: Terminated

Product Quantity: 7

Code Information:

Lot 3000061507

Distribution Pattern:

Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.

Voluntary or Mandated:

Voluntary: Firm initiated