Datascope recalls BEQ-TOP 27610 ECC Pack 3/8 Custom Tubing Kits (Catalog 701065622) due to potential air entry causing blood flow drops in ECMO circuits. Affected units include specific 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 certain BEQ-TOP 27610 Custom Tubing Kits because air can enter the device's housing, reducing blood flow in ECMO circuits. This could lead to serious complications for patients using extracorporeal membrane oxygenation systems.
The tubing kit's bladder component may separate from its housing, allowing air to enter. This can increase resistance in the venous line and reduce blood flow through the ECMO circuit, potentially causing serious complications.
Patients using ECMO systems with the recalled tubing kits are at risk. Healthcare providers who have the specific lot numbers listed in the recall are most affected.
Check for the product name 'BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit' with Catalog Number 701065622. Affected units include specific lots: 3000058734 and 3000063711.
Identify the catalog number and lot numbers listed in the recall notice to confirm if your unit is affected.
The Better Bladder device in the kit may separate from its housing, allowing air to enter and reducing blood flow in ECMO circuits.
Affected lots are 3000058734 and 3000063711.
The recall record does not specify a remedy, so no immediate fix is provided.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1721-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1721-2018 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.
