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 cardiopulmonary bypass equipment and/or related products.

Recall number

Z-0079-2012

Recalling firm

Medtronic Perfusion Systems

Product

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 cardiopulmonary bypass equipment and/or related products.

Status

Terminated

Initiated

2011-09-09

Posted

2011-10-20

Terminated

2012-10-11

Reason

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

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

74,804

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.

Lot, serial or model codes

Models 0K57R2, 0K82R15, 0M63R7, 0M68R6, 0N41R14, 0T50R5, 0V67R27, 0X52R3, 0Y35R, 0Y95R30, 0Z30R11, 1D41R16, 1F66R12, 1G59R1, 1J74R4, 1M90R8, 1P09R2, 2031R7, 2C88R8, 2C89R7, 2C90R7, 2C91R5, 2D61R2, 2D64R16, 2H08R3, 2K85R1, 2K87R1, 2K88R1, 2N90R9, 2T28R1, 3B74R2, 3T73R1, 3W29R, 4B42R5, 4C03R, 4D82R3, 4M55R, 4N04R, 4R43R, 5788R4, 5A45R3, 5B51R9, 5B94R, 5C33R2, 5C45R3, 5C92R9, 5D83R2, 5F68R1, 5G28R4, 5H65R, 5J00R2, 5P62R, 5W13R6, 5Z18R, 6G05R, 6J55R1, 6J88R4, 6J95R8, 6N12R, 6Q49R1, 6Q49R1, 6R08R, 6R09R, 6R44R2, 6S66R, 6S75R1, 6V25R, 6Y04R5, 6Y07R6, 6Y59R3, 7A69R4, 7A70R1, 7B56R1, CB0L44R16, CB0M02R5, CB0M79R8, CB1Q18R11, CB1S33R9, CB2D32R5, CB2W45R7, CB2W86R4, CB3K45R9, CB3K91R1, CB3M40R17, CB3Y46R9, CB3Y47R10, CB4800R18, CB4953R16, CB4958R16, CB4B68R8, CB4E78R7, CB4F45R15, CB4K64R6, CB4L83R4, CB4M60R2, CB4S43R9, CB4W10R10, CB4X84R, CB4Y71R14, CB4Z87R6, CB5A30R10, CB5F84R12, CB5J33R6, CB5L15R13, CB5L79R, CB5L90R16, CB5Q71R2, CB5Q74R1, CB5R04R1, CB5R46R5, CB5U81R, CB6A80R6, CB6G02R4, CB6H12R, CB6H45R4, CB6H76R, CB6H77R, CB6H78R, CB6J66R2, CB6J68R3, CB6J75R3, CB6L12R3, CB6L13R, CB6L14R, CB6L60R2, CB6M11R1, CB6Q15R, CB6Q16R1, CB6Q62R, CB6Q78R2, CB6S17R, CB6U12R, CB6U76R1, CB6X94R2, CB6X98R3, CB6Y02R6, CB6Y34R2, CB7C31R, DLP2X17R, HY0F32R17, HY2280R16, HY2U14R2, HY3U59R12, HY4A96R9, HY4V52R4, HY4V82R3, HY5D07R2, HY6B26R2, HY6G55R6, HY6G56R6, HY6H03R5, HY6H03R5, HY6J33R3, HY6J99R, HY6R36R1, HY6R36R1, HY6U70R2, HY6V34R2, HY6Z04R1, M331105H, M331105K, M336902L, M392810D, M392810E, M392811C, M392811D, M392811E, M440115G, M440115H, M440115J, M440115K, M440115L, M440129A, M440130A, M441002E, M443824F, M443825E, M492609A, M499301B, M530710A, M530710C, M530710D, M960208A, M960454B, P390806A, S330115A, SS6X67R1, SS6Z09R1, SSHY6E81R2, TL2H89R7, TL3Y45R1, TL3Z67R4, TL4E64R, TL4E66R10, TL4E66R10, TL5398R21, TL5C09R4, TL5M01R7, TL5R15R4, TL6A91R2, TL6C91R2, TL6D87R2, TL6H39R5, TL6W08R3, TL6X29R4, TL6X36R2, TL6X62R5, TL6Y92R, TL7A15R2.

510(k) numbers

["K852232"]

PMA numbers

not on file

Product code

DXS

Firm FEI

1000116158

Firm city

Brooklyn Park

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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