Events

Recall of Medtronic Ascenda(R) Intrathecal Catheter

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

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
    78406
  • Event Risk Class
    Class 3
  • Event Number
    Z-0537-2018
  • Event Initiated Date
    2017-09-21
  • Event Date Posted
    2018-02-06
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159486
  • 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
    Pump, infusion, implanted, programmable - Product Code LKK
  • Reason
    There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at the proximal end where the catheter connects to the drug infusion pump.
  • Action
    Medtronic on September 21, 2017, initiated a medical device recall and sent the following via mail (with delivery confirmation) to the consignees. In addition to the mailing, Medtronic field representatives may personally visit the accounts to provide the recall notification, assist the customer as necessary with locating and returning affected product(s), and verify that the customer has or will respond to Medtronic with the Customer Confirmation Form. For further questions, please call (800) 707-0933.

Device

Medtronic Ascenda(R) Intrathecal Catheter
  • Model / Serial
    (a) Model 8780: N740471001, N740482002, N740507001, N741669001, N741918005, N742124002, N742180002, N742214002, N743749002, N747547001, N740471002, N740482003, N740507002, N741669002, N742077001, N742124004, N742180003, N742214003, N743749004, N747547003, N740471003, N740482004, N740507003, N741669003, N742077002, N742124005, N742180004, N742214004, N743749005, N747547004, N740471004, N740482005, N740507004, N741669004, N742077003, N742124006, N742180006, N742214005, N743749006, N747547005, N740471005, N740482006, N740507005, N741669005, N742077004, N742143001, N742184003, N742942001, N743773001, N740471006, N740496001, N740507006, N741669006, N742077005, N742143002, N742184004, N742942002, N743773002, N740476001, N740496003, N740508001, N741677001, N742077006, N742143005, N742184005, N742942003, N743773003, N740476002, N740496004, N740508002, N741677002, N742088001, N742143006, N742184006, N742942004, N743773004, N740476004, N740496005, N740508003, N741677004, N742088002, N742151001, N742197001, N742942005, N743773005, N740476006, N740496006, N740508004, N741677006, N742088003, N742158002, N742197002, N742977001, N743800006, N740477001, N740500001, N740508006, N741688001, N742088004, N742158003, N742197003, N742977002, N744024001, N740477002, N740500003, N740511001, N741688002, N742088005, N742158004, N742197004, N742977003, N744024002, N740477003, N740500004, N740511002, N741688003, N742088006, N742158005, N742197005, N742977004, N744024003, N740477004, N740500005, N740511003, N741688004, N742093002, N742158006, N742197006, N742977005, N744024004, N740477005, N740500006, N740511004, N741688005, N742093004, N742172001, N742211001, N743157002, N744024005, N740477006, N740506001, N740511005, N741688006, N742093005, N742172002, N742211002, N743157003, N744024006, N740479003, N740506002, N740540002, N741918001, N742112003, N742172003, N742211003, N743157004, N747546001, N740479004, N740506003, N740540003, N741918002, N742112004, N742172004, N742211004, N743157005, N747546003, N740479005, N740506004, N740540005, N741918003, N742112006, N742172005, N742211005, N743157006, N747546004, N740482001, N740506006, N740540006, N741918004, N742124001, N742180001, N742214001, N743749001, N747546005   (b) Model 8781: N745579001, N745579002, N745579005, N745579006, N746858001  (c) Model 8784: N745557001, N745557002, N745557003, N745557004, N745557005
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Medtronic Ascenda(R) Intrathecal Catheter, Models: || (a) 8780, UDI: 00643169202122, 00643169783027 || (b) 8781, UDI: 00643169202139 || (c) 8784, UDI: 00643169202153 || The Ascenda Intrathecal Catheter kits (models 8780, 8781 and 8784) contain parts of an infusion system that delivers drugs to the intrathecal space. The implanted system consists of an implantable infusion pump and an Ascenda catheter. The catheter connects to the pump at the catheter port and enters the intrathecal space.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • Manufacturer Address
    Medtronic Neuromodulation, 7000 Central Ave Ne, Minneapolis MN 55432-3568
  • 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