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Gauge, Pressure, Coronary, Cardiopulmonary Bypass

FDA product code DXS · Class 2 · Cardiovascular

8
Registered devices
2
Adverse events
5
Recalls
13
510(k) clearances

Devices with this code

DLP® — MEDTRONIC, INC.DLP® — MEDTRONIC, INC.NA — MEDTRONIC, INC.DLP® — MEDTRONIC, INC.PRESSURE GAUGE ISOLATOR KIT — NOVOSCI CORP.DLP® — MEDTRONIC, INC.DLP® — MEDTRONIC, INC.DLP® — MEDTRONIC, INC.

Recent recalls

DateFirmReason
2024-03-19Medtronic Perfusion SystemsPotential for unsealed sterile packing.
2017-06-22Medtronic Perfusion SystemsIdentification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
2011-09-09Medtronic Perfusion SystemsThe DFU for the Medtronic Pressure Display Box, model 66000, states that, for display readings of -100 to +300 mmHg there will be an accuracy of +/-5 mmHg, and
2011-09-09Medtronic Perfusion SystemsPressure Display Set (models 61000, 61006, 62000, 62006) DFU will be updated to clarify that the intended use of the disposables is only for cardiopulmonary byp
2011-09-09Medtronic Perfusion SystemsPressure Display Set (models 61000, 61006, 62000, 62006) DFU will be updated to clarify that the intended use of the disposables is only for cardiopulmonary byp

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