Class II — Datascope Corporation
| Recalling firm | Datascope Corp. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02 |
| Quantity | 10 |
| Distribution | Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA. |
| Initiated | 2017-10-19 |
| Classified | 2018-05-08 |
| Terminated | 2020-04-24 |
| Recall number | Z-1718-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Datascope Corporation (Z-1718-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79873/
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