Datascope recalls BEQ-TOP 33700 ECC 3/8" Custom Tubing Packs with Bioline Coating (Catalog No. 701053845) due to potential air entry into ECMO circuits, risking blood flow drops. Affected units have specific lot numbers.
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.
Datascope is recalling certain custom tubing packs for ECMO use because air can enter the device, causing blood flow problems in the circuit. This could lead to reduced blood flow in the ECMO system, which is critical for patients on life support.
The tubing pack's seal may separate from the housing, allowing air to enter the device. This air can collapse the balloon inside, increasing resistance in the venous line and reducing blood flow through the ECMO circuit.
Patients using ECMO life support systems with this specific tubing pack are most at risk. Healthcare providers who use the recalled product for medical procedures may also be affected.
Check for the product name 'BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating' and catalog number 701053845. Affected units have lot numbers 3000056811, 3000063949, or 3000067795.
Identify the catalog number (701053845) and lot numbers (3000056811, 3000063949, 3000067795) to confirm if your unit is affected.
The seal may separate from the housing, allowing air to enter the device and collapse the balloon, which can reduce blood flow in the ECMO circuit.
Check the catalog number and lot numbers to see if your unit is affected. If it is, contact Datascope for further instructions.
The recall states that air entry could reduce blood flow in the ECMO circuit, which is critical for patients on life support, but the remedy is not specified in the record.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1716-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1716-2018 from Datascope. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
