FDA Device Intelligence
HomeDevice types › DWE

Tubing, Pump, Cardiopulmonary Bypass

FDA product code DWE · Class 2 · Cardiovascular

3,184
Registered devices
1,866
Adverse events
48
Recalls
21
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2019-07-03LivaNova USA Inc.Perfusion tubing pack was packaged with the incorrect cuvette.
2017-12-19LivaNova USAThe product is labeled with the incorrect expiration date.
2017-10-19Datascope CorporationThe 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 e
2017-10-19Datascope CorporationThe 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 e
2017-10-19Datascope CorporationThe 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 e
2017-10-19Datascope CorporationThe 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 e
2017-10-19Datascope CorporationThe 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 e
2017-10-19Datascope CorporationThe 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 e
2017-07-27Datascope CorporationThere is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
2017-07-27Datascope CorporationThere is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.