Datascope recalls BEQ-TOP 41201 ECC 3/8 PUMP PAC with custom tubing kits due to potential air entry causing blood flow drops in ECMO circuits. Affected units have specific catalog numbers and lots.
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 some BEQ-TOP 41201 ECC 3/8 PUMP PAC custom tubing kits because a seal issue might let air into the device, reducing blood flow in ECMO systems. This could lead to serious complications for patients using extracorporeal membrane oxygenation.
The seal between the tubing and housing can separate, allowing air to enter the device. This may cause blood flow to drop in the ECMO circuit, potentially leading to serious complications for patients.
Patients using ECMO systems with this specific tubing kit are most at risk. The recall affects medical devices sold to hospitals and clinics.
Check for catalog number 701064867 on the tubing kit. Affected units were sold with lot numbers 3000057376 or 3000063289.
Inspect the tubing kit for seal separation that might allow air to enter the housing.
Yes, the seal separation could allow air to enter the device, potentially reducing blood flow in ECMO circuits and causing serious complications.
Check for catalog number 701064867 and lot numbers 3000057376 or 3000063289. If affected, contact Datascope for guidance.
Look for catalog number 701064867 and lot numbers 3000057376 or 3000063289 on the product label.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1730-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1730-2018 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.
