Events

Recall of (2) Fortify-Assura (CD 1259-40, CD 1259-40 Q, CD 2259-40, CD 2259-40 Q, CD 1359-40, CD 1255-40, (3) Heart Minder ST (CD 1299-40, CD 1299-40 Q, CD 2299-40, CD 2299-40 Q, CD 2259-40, (5) Unify (CD3235-40, CD3235-40Q) (6) Unify Assura (CD 3361-40, CD 3361-40C) (4) Heart Minder + (CD 1391-40C, CD 1391-40 QC, CD 2391-40 C, CD 231-40 QC) (8) QUADORA ASSURA (CD 3367-40, CD 3367-40C, CD 3367-40Q, CD 3367-40 QC) (9) Excelis CRT (CD3367-40, CD3367-40QC) (7) Unified Quadra (CD3251-40, CD3251-40Q) (11) Exelis + CRT-D (CD3389-40C, CD3389-40Q, CD3389-40QC) (11) Excises + CRT-D (CD3389-40C, CD3389-40Q, CD3389-40QC) (10) Quadra + Excellis (CD3385-40C, CD3385-40Q, CD3385-40QC) (12) Exelis Quadra (CD 3281 - 40, CD 3281 - 40 Q)

According to Pharmaceuticals and Medical Devices Agency, Japan, this recall involved a device in Japan that was produced by St. Jude Medical Co., Ltd..

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
    1-0964
  • Date
    2016-10-12
  • Event Country
    Japan
  • Event Source
    PMDAJ
  • Event Source URL
    http://www.info.pmda.go.jp/rgo/MainServlet?recallno=1-0964
  • Notes / Alerts
    Japanese data is current through August 2018. All of the data comes from the Japanese Pharmaceuticals and Medical Devices Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Japan.
  • Extra notes in the data
    2016/10/25 "2. Correction of target lot, quantity and shipping time"

Device

(2) Fortify-Assura (CD 1259-40, CD 1259-40 Q, CD 2259-40, CD 2259-40 Q, CD 1359-40, CD 1255-40, (...
  • Model / Serial
  • Product Description
    (1) - (12) Automatic implantable defibrillator, implantable biventricular pacing pulse generator with defibrillation function
  • Manufacturer
    St. Jude Medical Co., Ltd.

Manufacturer

St. Jude Medical Co., Ltd.
  • 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
    PMDAJ