Events

Recall of Medtronic Disposable Pressure Display Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Perfusion Systems.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59948
  • Event Risk Class
    Class 2
  • Event Number
    Z-0079-2012
  • Event Initiated Date
    2011-09-09
  • Event Date Posted
    2011-10-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104363
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Gauge, pressure, coronary, cardiopulmonary bypass - Product Code DXS
  • 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.
  • 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.

Device

Medtronic Disposable Pressure Display Set
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    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.
  • Manufacturer
    Medtronic Perfusion Systems

Manufacturer

Medtronic Perfusion Systems
  • Manufacturer Address
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA