Home › Device 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
NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.Intersept® — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.UF Pediatric Adapted Circuit — DATASCOPE CORP.1/4" with Bridge Ancillary Pack — DATASCOPE CORP.Quadrox iD Pack — DATASCOPE CORP.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-07-03 | LivaNova USA Inc. | Perfusion tubing pack was packaged with the incorrect cuvette. |
| 2017-12-19 | LivaNova USA | The product is labeled with the incorrect expiration date. |
| 2017-10-19 | Datascope Corporation | 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 e |
| 2017-10-19 | Datascope Corporation | 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 e |
| 2017-10-19 | Datascope Corporation | 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 e |
| 2017-10-19 | Datascope Corporation | 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 e |
| 2017-10-19 | Datascope Corporation | 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 e |
| 2017-10-19 | Datascope Corporation | 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 e |
| 2017-07-27 | Datascope Corporation | There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through. |
| 2017-07-27 | Datascope Corporation | There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through. |
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