Datascope recalls BEQ-TOP 22702 ECC W/HMOD 30000 (Catalog 701051179) due to potential air entry in ECMO circuits causing 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 BEQ-TOP 22702 ECC W/HMOD 30000 ECMO tubing kits because seal separation might let air into the system. This could reduce blood flow in the ECMO circuit, risking serious complications for patients using the device.
The tubing kit's seal can separate from the housing, allowing air to enter the ECMO circuit. This air entry increases resistance in the venous line, which may cause blood flow to drop significantly in the circuit.
Patients using ECMO systems with this specific tubing kit are most at risk. Healthcare providers who have purchased or installed these kits may also be affected.
Check for the model BEQ-TOP 22702 ECC W/HMOD 30000 with Catalog Number 701051179. Affected units were sold with Lot Number 3000058051.
Inspect the tubing kit for seal separation from the housing, which could allow air to enter the ECMO circuit.
The recalled model is BEQ-TOP 22702 ECC W/HMOD 30000 with Catalog Number 701051179.
Check for the model BEQ-TOP 22702 ECC W/HMOD 30000 with Catalog Number 701051179 and Lot Number 3000058051.
The recall record 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-1712-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1712-2018 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.
