Events

Recall of Device Recall Medtronic Carmedacoated

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
    48100
  • Event Risk Class
    Class 2
  • Event Number
    Z-1920-2008
  • Event Initiated Date
    2008-05-09
  • Event Date Posted
    2008-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70942
  • 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
    device for Cardiopulmonary Bypass - Product Code DTZ
  • Reason
    Medtronic is recalling selected carmeda-coated cardiopulmonary bypass (cpb) products (e.G., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. medtronic's heparin supplier recently reported that it had provided some batches to medtronic that were contaminated with oversulfated chondroitin sulfate (oscs).
  • Action
    Medtronic issued a Press Release on 05/07/2008. An Urgent Medical Device Recall letter was sent to customers on May 07, 2008. The letter identifies affected devices, explains the situation and requests that the impacted product be returned to Medtronic for disposal. The end user will be requested to complete a Recall Certificate acknowledging the receipt of this information.

Device

Device Recall Medtronic Carmedacoated
  • Model / Serial
    Catalog / Lot: CB0B90R3 / 9871463, CB0L44R15 / 9904942, CB0X97R10 / 9818263, CB1V99R2 / 9887322, CB1Y06R14 / 9872639, CB1Z42R15 / 9568381, CB1Z69R12 / 9805685, CB1Z69R12 / 9819156, CB1Z85R16 / 9816273, CB2503R1 / 9879856, CB2K59R8 / 9816253, CB2K59R8 / 9819175, CB2S52R4 / 9882568, CB2U05R1 / 9834608, CB2W86R2 / 9812228, CB3E29R5 / 9819173, CB3L87R4 / 9839338, CB3U53R7 / 9894969, CB3X44R4 / 9837298, CB4741R15 / 9823284, CB4E05R6 / 9892093, CB4F32R3 / 9819157, CB4F32R3 / 9819650, CB4F32R3 / 9867648, CB4G10R5 / 9885608, CB4Q81R / 9866753, CB4S04R2 / 9841997, CB4T12R2 / 9861563, CB4W67R3 / 9837302, CB5N65R2 / 9904072, HY1709R34 / 9818265, HY3B29R13 / 9895128, HY4X31R7 / 9864540, HY5C74R15 / 9838652, HY5H32R5 / 9879895, HY5L38R1 / 9859513, HY5L72R1 / 9882604, HY5R03R / 9861103, TL2L66R5 / 9859465
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
  • Product Description
    Medtronic Extracorporeal Circuit with bio-active surface; Cardiopulmonary Bypass Oxygenator, Catalog Numbers: CB0B90R3, CB0L44R15, CB0X97R10, CB1V99R2, CB1Y06R14, CB1Z42R15, CB1Z69R12, CB1Z69R12, CB1Z85R16, CB2503R1, CB2K59R8, CB2K59R8, CB2S52R4, CB2U05R1, CB2W86R2, CB3E29R5, CB3L87R4, CB3U53R7, CB3X44R4, CB4741R15, CB4E05R6, CB4F32R3, CB4F32R3, CB4F32R3, CB4G10R5, CB4Q81R, CB4S04R2, CB4T12R2, CB4W67R3, CB5N65R2, HY1709R34, HY3B29R13, HY4X31R7, HY5C74R15, HY5H32R5, HY5L38R1, HY5L72R1, HY5R03R, and TL2L66R5.
  • 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