Datascope recalls BEQ-TOP 5210 ECC Set respiratory tubing kits due to potential air entry causing ECMO circuit blood flow drops. 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 5210 ECC respiratory tubing kits because a seal issue might let air enter the device, reducing blood flow in ECMO circuits. 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 air entry increases resistance in the venous line, which may cause blood flow in the ECMO circuit to drop. Reduced blood flow can lead to serious complications for patients on ECMO.
Patients using extracorporeal membrane oxygenation (ECMO) with this specific tubing kit are most at risk. Healthcare providers who use the BEQ-TOP 5210 ECC Set for respiratory support may also be affected.
Check for catalog number 701055604R01 on the kit. Affected units were sold with lot numbers 3000061303 or 3000056130.
Inspect the tubing kit for seal separation that might allow air to enter the housing.
Yes, the seal separation can allow air entry, increasing resistance and potentially causing blood flow drops in ECMO circuits.
The recall record does not specify a remedy, so contact Datascope Corporation for guidance.
Look for catalog number 701055604R01 and lot numbers 3000061303 or 3000056130.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1709-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1709-2018 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.
