Events

Recall of Device Recall MitraXs" Self Adjusting Atrial Retractor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by St. Jude Medical Cardiovascular Division.

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
    57850
  • Event Risk Class
    Class 2
  • Event Number
    Z-1370-2011
  • Event Initiated Date
    2011-01-26
  • Event Date Posted
    2011-02-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97576
  • 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
    Instruments, surgical, cardiovascular - Product Code DWS
  • Reason
    St. jude medical cardiovascular division is conducting a voluntary recall of all batches and model numbers of the mitraxs self adjusting atrial retractor. st. jude medical has been distributing this product since their acquisition of clr in late 2008. they have determined that some distributed batches have very small burrs on the polycarbonate material at the distal edge. as these burrs may.
  • Action
    The firm, St. Jude Medical, sent an "Urgent Medical Device Recall Notice" dated January 26, 201,1 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to discontinue use of the product (MitraXs Self Adjusting Atrial Retractor batches) and remove from inventory. St. Jude began production of a new batch of units that will bear the labeling of St. Jude Medical. Shipment of these units started on January 10, 2011. Note: A St. Jude Medical Sales Representative will contact the customer to facilitate removal and reconciliation of the affected product. If you have any questions or concerns, please contact your St. Jude Medical Sales Representative or 651-490-4470 and/or 612-310-7936.

Device

Device Recall MitraXs" Self Adjusting Atrial Retractor
  • Model / Serial
    Model - Batch #:  A0030/1 - 32730001; 32765005; 33253005; 347830070  A0031/1 - 32730003; 32765007; 347830080; 33253006  A0032/1 - 32730002; 32765006; 34783090; 32985001  A0033/1 - 32765008; 33253007; 347830100
  • Product Classification
    Cardiovascular Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: NJ, OH, MI, and MN; and countries including: BELGIUM, FRANCE, GERMANY, SWITZERLAND, and UNITED KINGDOM.
  • Product Description
    MitraXs" Self Adjusting Atrial Retractor, Sterile EO, Models (REF): A0030/1; A0031/1; A0032/1; A0033/1, Cardio Life Research s.a., Green Hill, Hoge Wei, 16, B-1930 Zaventem, Belgium. || Indicted for the retraction of the atrium walls during mitral or tricuspid cardiac surgery.
  • Manufacturer
    St. Jude Medical Cardiovascular Division

Manufacturer

St. Jude Medical Cardiovascular Division
  • Manufacturer Address
    St. Jude Medical Cardiovascular Division, 14901 Deveau Pl, Minnetonka MN 55345-2126
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA