Recalls for Gauge, Pressure, Coronary, Cardiopulmonary Bypass

Potential for unsealed sterile packing.

Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

The 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 for display readings of +301 to +500 mmHg there will be an accuracy of +/-10 mmHg. Through reports from customers, Medtronic has become aware that the Pressure Display Box may not always accurately display readings. During use in the -40

Pressure Display Set (models 61000, 61006, 62000, 62006) DFU will be updated to clarify that the intended use of the disposables is only for cardiopulmonary bypass surgery (procedures up to 6 hours). Use beyond 6 hours may result in air leakage in the system resulting in a pressure reading that is not representative of the actual line pressure.

Pressure Display Set (models 61000, 61006, 62000, 62006) DFU will be updated to clarify that the intended use of the disposables is only for cardiopulmonary bypass surgery (procedures up to 6 hours). Use beyond 6 hours may result in air leakage in the system resulting in a pressure reading that is not representative of the actual line pressure.