Events

Rappel de Medtronic Disposable Pressure Display Set

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Medtronic Perfusion Systems.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    59948
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0079-2012
  • Date de mise en oeuvre de l'événement
    2011-09-09
  • Date de publication de l'événement
    2011-10-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-10-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104363
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Gauge, pressure, coronary, cardiopulmonary bypass - Product Code DXS
  • Cause
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “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