Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BEQ-TOP 38900 ECC PACK Recalled by Datascope Corporation Due to The Better Bladder device provided as part of...

Date: October 19, 2017
Company: Datascope Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Datascope Corporation directly.

Affected Products

BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368

Quantity: 9

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 13 states: AL, AR, CA, FL, IL, LA, MO, NC, PA, SC, TX, WA, DC

Affected (13 states)Not affected

About Datascope Corporation

Datascope Corporation has 67 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report