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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Pressure Display Box

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  Class 2 Device Recall Medtronic Pressure Display Box see related information
Date Initiated by Firm September 09, 2011
Date Posted October 20, 2011
Recall Status1 Terminated 3 on October 11, 2012
Recall Number Z-0077-2012
Recall Event ID 59948
510(K)Number K852232  
Product Classification Gauge, pressure, coronary, cardiopulmonary bypass - Product Code DXS
Product Medtronic Pressure Display Box, Models 66000, 64000, 63000, 60000. It is capable of measuring pressure between -100 mmHg and +500 mmHg with an accuracy of +/-5 mmHg from -100 mmHg to +300 mmHg and +/-10 mmHg from +301 to +500 mmHg. The Pressure Display Box has an upper and lower alarm setting. The alarm will be activated when the pressure is equal to or beyond the set value. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55431-5604.

Product Usage: This product is intended for use in displaying line pressures during cardiopulmonary bypass surgery.
Code Information serial numbers: 301010, 301012, 301013, 301015, 301016, 301017, 301018, 301019, 301020, 301023, 301024, 301025, 301026, 301027, 301029 thru 301041, 301043 thru 301050, 301052, 301053, 301054, 301055, 301056, 301057, 301058, 301060, 301061, 301062, 301063, 301068 thru 301085, 301087, 301088, 301090, 301091, 301092, 301093, 301094, 301300, 301301, 301302, 301303, 301371 thru 301383, 301385, 301387, 301388, 301389, 301390, 301394, 301396, 301397, 301399 thru 301407, 301409, 301410, 301431 thru 301450, 301460, 301461, 301462, 301464, 301467 thru 301485, 301487 thru 301507, 301509 thru 301526, 301560 thru 301663, 301665 thru 301704, 301707 thru 301751, 301753, 301754, 301755, 301756, 301758 thru 301817, 301819 thru 301842, 301844 thru 302148, 302150 thru 302161,   PDBR400000 thru PDBR400127, PDBR400129 thru PDBR400835, PDBR400847 thru PDBR401104, PDBR401107 thru PDBR401178.
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information Contact Medtronic Cardiovascular Tech Support
877-526-7890
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity in Commerce 1694 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 Rica, Croatia, Cyprus, Czech Republic, Denmark, El Salvador, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Latvia, Lebanon, Libya, Malaysia, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Venezuela, and Yemen.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXS and Original Applicant = DLP, INC.
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