Medtronic Disposable Pressure Display Set, Models 61000, 61006, 62000, 62006. Sterilized by Ethylene Oxide. Non-pyrogeni

FDA device recall Z-0078-2012 · posted 2011-10-20 · Terminated

Recall details

Recalling firm

Medtronic Perfusion Systems

Reason for recall

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.

Action taken

Medtronic 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 further distributed, forward this letter immediately to all customers who received the affected products, and gather proof of notification. For further questions concerning this notification, contact Medtronic Cardiovascular Technical Support at 877-526-7890 or Medtronic Sales Representative.

Root cause

Device Design

Status

Terminated

Product code

DXS

Quantity affected

193,590 units

Distribution

Worldwide 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

Date initiated

2011-09-09

Date posted

2011-10-20

Date terminated

2012-10-11

Location

Brooklyn Park, MN

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