Events

Recall of Device Recall Tubing Pack

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
    78977
  • Event Risk Class
    Class 2
  • Event Number
    Z-0535-2018
  • Event Initiated Date
    2018-01-03
  • Event Date Posted
    2018-01-30
  • 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=160995
  • 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
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Reason
    Medtronic custom perfusion tubing packs contain terumo ops valves that were recalled due to a lack of flow through the valve.
  • Action
    In response to an Urgent Safety Alert issued by Terumo Cardiovascular Systems (CVS) Medtronic initiated their safety alert verbally to their direct consignees on 10/23/2017, providing them with a copy of the Terumo Safety Alert dated 06/27/2017. The firm followed this action with a letter on 1/3/18 in which they stated that the action by Terumo CVS was changed to a recall, and , in response, Medtronic was following up as a recall and requested the products be returned.

Device

Device Recall Tubing Pack
  • Model / Serial
    a) REF 2815R1, UPN/GTIN: 20885074191038, Lot/Serial Numbers: 210937492, 213151103, 213671744  b) REF 2D25R6, UPN/GTIN: 00613994268174, Lot/Serial Numbers: 209533592, 209759280, 209948919, 210174899, 210377603,  210478517, 210591995, 210767149, 211011818, 211210404,  211243436, 211542842, 211761616  c) REF 9M68R, UPN/GTIN: 20643169876648, Lot/Serial Numbers: 212067087, 212796361  d) REF BB4B15R13, UPN/GTIN: 00643169845121, Lot/Serial Numbers: 211804184, 212073924, 212266962, 212268301, 212385983, 212552883,  212796215, 213248430, 213583108  e) REF BB4B15R14, UPN/GTIN: 00763000025878, Lot/Serial Numbers: 213801240, 213868837  f) REF BB9L72R, UPN/GTIN: 00643169845077, Lot/Serial Numbers: 211715103  g) REF BB9L72R1, UPN/GTIN: 00643169872127, Lot/Serial Numbers:  212020797, 212174623, 212193001, 212301586, 212355584, 212428238,  212626142, 212884370, 213001157, 213248459, 213631247, 213672934,  213802501, 214072742, 214093025  h) REF CB1Z87R11, UPN/GTIN: 00643169741591, Lot/Serial Numbers: 211755326  i) REF CB4L56R24, UPN/GTIN: 00643169735989, Lot/Serial Numbers: 211654744, 211654745, 211800954  j) REF CB4L56R26, UPN/GTIN: 00643169906181, Lot/Serial Numbers: 212294432, 212404544, 212447345, 212489670, 213251146, 213251166,  213358174, 213573495, 213623995, 214053395  k) REF CB5S68R3, UPN/GTIN: 20613994490760, Lot/Serial Numbers: 210937507  l) REF CB7X82R4, UPN/GTIN: 00643169471986, Lot/Serial Numbers: 211050766, 211320749  m) REF CB7X82R5, UPN/GTIN: 00643169789517, Lot/Serial Numbers:  211423503, 211443209, 211443210, 211885323, 211991293, 212154744,  212235237, 212274655, 212428312, 212473311, 212671632, 212962650,  213126447, 213292357, 213377926, 213445426, 213494394, 213494396,  213672914, 213906498, 214043035, 214093030  n) REF HY6Y19R5, UPN/GTIN: 00643169510432, Lot/Serial Numbers: 210802114, 210945613, 211114272, 211210180, 211327621, 211654742,  211846417, 212235012, 212545229, 212835348  o) REF HY8M65R2, UPN/GTIN: 00643169661295, Lot/Serial Numbers: 210952226, 211335076, 211558225, 211722651, 212028419, 212222066,  212355669, 213001001, 213719738  p) REF TL8W39R6, UPN/GTIN: 00643169715097, Lot/Serial Numbers: 210731697, 210838201, 210937704
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    DE, IA, CA and Japan
  • Product Description
    Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
  • 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