Datascope recalls BEQ-TOP 33500 3/8" ECC PACK (Catalog No. 701053752) due to potential air entry causing ECMO circuit blood flow drops. Affected units have Lot 3000056255.
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 a specific ECMO tubing kit component because air could enter the device and reduce blood flow in life-support systems. This poses a risk to patients using extracorporeal membrane oxygenation (ECMO) therapy.
The device's seal may separate, allowing air to enter the housing. This can collapse the balloon inside, increasing resistance in the venous line and reducing blood flow through the ECMO circuit.
Patients using ECMO therapy with this specific tubing kit component are most at risk. Healthcare providers who use the recalled product for medical treatments may also be affected.
Check for the BEQ-TOP 33500 3/8" ECC PACK with Catalog Number 701053752 and Lot Number 3000056255. This product was sold as part of custom tubing kits for ECMO systems.
Identify the catalog number (701053752) and lot number (3000056255) on the product.
The recall states that seal separation may occur, so it is not safe even with proper use.
Air entry could collapse the balloon, reducing blood flow in the ECMO circuit and potentially causing harm.
The recall does not specify a remedy, so contact Datascope Corporation for guidance.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1710-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1710-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
