ClearanceBrief
Recall Z-0079-2012 ยท DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass

Medtronic Perfusion Systems

Medtronic Intersept Custom Tubing Pack, which are designed as specified by the user. The following models contain a Pressure Display Set. Sterilized by Ethylene Oxide. Non-pyrogenic. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604. Product Usage: This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopul

DateOct 20, 2011 (initiated Sep 9, 2011)
StatusTerminated
ReasonPressure 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.
Root causeDevice Design
ActionMedtronic Perfusion Systems, sent an "Urgent Medical Device Notification letter dated September 9, 2011, via UPS 2-day delivery to all affected customers. The letter identified the affected devices, described the issues, and the actions needed to be taken. The letter indicates when approved, the updated Directions for Use for the Pressure Display Box and Pressure Display Sets will be sent to customers. Customers were asked to complete the Customer Confirmation Certificate and return to Medtronic per the instructions on the form. The letter states that if the recalled products have been fu
Quantity74,804
DistributionWorldwide Distribution - USA (nationwide) including Puerto Rico, and Virgin Islands (U.S.) and the countries of: Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, El Salvador, France, Georgia, Germany, Greece, Hon
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K852232PRESSURE DISPLAY BOX #60000/TUBING SET #61000
Dlp, Inc., Aug 9, 1985