Z-0078-2012

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

Name: Z-0078-2012 Medtronic Disposable Pressure Display Set, Models 61000, 61006, 62000, 62006. Sterilized by Ethylene Oxide...
Creator: Medtronic Perfusion Systems
Published: 2011-09-09
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2011-09-09 / Terminated / root cause: design

FDA source

Medtronic Perfusion Systems began a recall of Medtronic Disposable Pressure Display Set, Models 61000, 61006, 62000, 62006. Sterilized by Ethylene Oxide. Non-pyrogenic. Coiled PVC tubing with threaded... on 2011-09-09. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0078-2012
Status: Terminated
Initiated: 2011-09-09
Posted: 2011-10-20
Terminated: 2012-10-11
Recalling firm: Medtronic Perfusion Systems
Product: Medtronic Disposable Pressure Display Set, Models 61000, 61006, 62000, 62006. Sterilized by Ethylene Oxide. Non-pyrogenic. Coiled PVC tubing with threaded transducer dome (acrylic) with silicone diaphragm on proximal end. Product utilizes a stopcock on proximal and/or distal end. Distal end of tubing features a male luer port. 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 cardiopulmonary bypass equipment and/or related products.
Product code: DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass
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.
Root cause tag: design
FDA root cause: 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: 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 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.
Product codes and lots: Lot numbers: 2008070788, 2008070792, 2008070793, 2008070955, 2008080357, 2008080359, 2008080385, 2008080426, 2008080441, 2008080525, 2008080545, 2008081109, 2008081195, 2008090080, 2008090244, 2008090980, 2008091122, 2008091123, 2008091125, 2008100001, 2008100531, 2008100583, 2008100605, 2008100607, 2008101323, 2008101324, 2008101325, 2008101368, 2008101375, 2008101379, 2008101380, 2008110008, 2008110173, 2008110287, 2008110301, 2008110530, 2008110531, 2008110612, 2008110720, 2008110876, 2008110877, 2008110878, 2008111157, 2008111209, 2008111210, 2008120149, 2008120150, 2008120478, 2008120848, 2008120849, 2008120850, 2008120851, 2008121107, 2009010121, 2009010122, 2009010603, 2009010604, 2009010605, 2009010953, 2009010954, 2009010955, 2009011280, 2009011281, 2009011282, 2009011283, 2009011284, 2009020119, 2009020581, 2009020841, 2009020842, 2009020843, 2009030102, 2009030327, 2009030328, 2009030329, 2009030330, 2009030626, 2009030955, 2009031171, 2009031172, 2009040538, 2009040539, 2009040540, 2009040541, 2009040834, 2009041092, 2009041093, 2009041094, 2009050183, 2009050527, 2009050528, 2009050529, 2009050867, 2009050868, 2009050975, 2009050976, 2009060054, 2009060381, 2009060382, 2009060383, 2009060633, 2009060640, 2009060641, 2009060642, 2009060696, 2009061139, 2009070210, 2009070487, 2009070488, 2009070912, 2009071231, 2009080403, 2009080404, 2009080405, 2009080406, 2009080407, 2009081128, 2009081129, 2009081130, 2009081131, 2009081851, 2009090137, 2009090589, 2009090590, 2009090591, 2009091085, 2009100116, 2009100118, 2009100443, 2009100444, 2009100445, 2009100446, 2009100882, 2009100974, 2009100975, 2009100976, 2009100977, 2009100978, 2009101597, 2009101598, 2009102220, 2009102221, 2009102222, 2009110186, 2009110859, 2009110861, 2009111388, 2009112071, 2009120316, 2009120317, 2009120788, 2009120789, 2009120790, 2009120791, 2009121304, 2009121305, 2009121306, 2009121701, 2009121704, 2010010236, 2010010237, 2010010238, 2010011329, 2010011330, 2010011525, 2010011526, 2010011527, 2010021286, 2010022073, 2010022074, 2010031328, 2010031329, 2010031330, 2010031331, 2010031332, 2010031333, 2010032084, 2010032085, 2010032086, 2010032087, 2010032816, 2010032817, 2010032818, 2010032819, 2010032820, 2010033477, 2010033478, 2010033479, 2010040563, 2010040564, 2010040947, 2010040948, 2010040949, 2010041433, 2010050370, 2010050371, 2010050726, 2010050963, 2010051276, 2010051363, 2010060108, 2010060280, 2010060558, 2010060689, 2010061703, 2010061759, 2010062023, 2010062558, 2010062870, 2010062871, 2010070115, 2010071372, 2010071373, 2010071375, 2010071377, 2010071570, 2010071868, 2010080229, 2010080231, 2010080810, 2010080811, 2010080812, 2010081270, 2010081424, 2010081602, 2010081604, 2010081606, 2010082011, 2010082012, 2010082218, 2010082219, 2010082439, 2010090223, 2010090420, 2010090497, 2010090615, 2010090759, 2010090939, 2010090952, 2010091040, 2010091666, 2010091802, 2010092208, 2010092209, 2010092472, 2010092505, 2010100038, 2010100237, 2010100249, 2010100374, 2010100376, 2010100681, 2010101291, 2010101293, 2010101374, 2010101385, 2010101493, 2010101961, 2010101974, 2010110030, 2010110033, 2010110974, 2010120220, 2010120424, 2010120605, 2010120606, 2010121586, 2010121587, 2010122170, 2010122208, 2011010069, 2011010367, 2011010368, 2011011063, 2011011067, 2011011311, 2011011454, 2011011931, 2011020018, 2011020019, 2011020217, 2011020218, 2011020581, 2011020583, 2011020585, 2011020955, 2011020956, 2011021012, 2011021014, 2011021155, 2011021156, 2011021157, 2011021668, 2011021669, 2011021991, 2011021993, 2011022187, 2011022188, 2011030015, 2011030089, 2011030090, 2011030095, 2011030155, 2011030156, 2011030311, 2011030312, 2011031091, 2011031094, 2011031450, 2011031610, 2011031611, 2011031685, 2011032335, 2011032336, 2011040004, 2011040025, 2011040026, 2011040260, 2011040261, 2011040365, 2011040366, 2011040811, 2011040812, 2011041038, 2011041070, 2011041092, 2011041194, 2011041306, 2011041307, 2011041573, 2011041574, 2011041590, 2011041592, 2011050006, 2011050362, 2011050363, 2011050397, 2011050398, 2011050657, 2011050697, 2011051009, 2011051238, 2011051239, 2011051381, 2011051382, 2011051696, 2011051704, 2011060013, 2011060014, 2011060184, 2011060373, 2011060375, 2011060551, 2011060680, 2011060726, 2011060786, 2011061269, 2011061271, 2011062118, 2011062119, 2011062400, 2011062401, 2011062402, 2011070035, 2011070036, 2011070285, 2011070287, 2011070847, 2011070848, 200806C084, 200806C089, 200808C026, 200808C094, 200808C109, 200811C004, 200811C005, 200811C038, 200812C005, 200903C075, 200905C126, 200908C163, 200908C164, 200910C047, 200910C175, 200910C182, 200910C183, 200911C085, 200912C010, 201001C087, 201002C045, 201002C135, 201005C040, 201006C018, 201007C033, 201008C040, 201009C132, 201009C180, 201009C181, 201011C104, 201011C132, 201011C139, 201012C042, 201101C032, 201102C103, 201103C061, 201104C019, 201104C064, 201104C106, 201105C057.

Product code DXS

K852232Class IIPressure Display Box #60000/Tubing Set #61000Dlp, Inc. / cleared 1985-08-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)