Events

Recall of PARADYM DR ICD

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LIVANOVA CANADA CORP..

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
    51709
  • Event Risk Class
    II
  • Event Initiated Date
    2017-04-12
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Livanova is notifying physicians of the possibility of undetectable battery depletion in the event of recurrent shock capacitor charging and what actions to take to mitigate risks associated with the issue.

Device

PARADYM DR ICD
  • Model / Serial
    Model Catalog: 8550 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 154 (Lot serial: 502AE011); Model Catalog: 154 (Lot serial: 449AE042); Model Catalog: 9750 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 154 (Lot serial: 448AE007); Model Catalog: 154 (Lot serial: 446AE033); Model Catalog: 154 (Lot serial: 502AE09E); Model Catalog: 6550 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 6750 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 9770 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 8770 (Lot serial: 933YI050); Model Catalog: 8770 (Lot serial: 019YI02F); Model Catalog: 8770 (Lot serial: 019YI034); Model Catalog: 8770 (Lot serial: 015YI081); Model Catalog: 9550 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 9250 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 8750 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 8250 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 6250 (Lot serial: >100 NUMBERS CONTACT MFR)
  • Product Description
    PARADYM DR ICD 8550;INTENSIA DR ICD 154;PARADYM RF CRT-D 9750;OVATIO DR ICD 6550;OVATIO CRT-D 6750;PARADYM RF SONR CRT-D 9770;PARADYM SONR CRT-D PHD 8770;PARADYM RF DR ICD 9550;PARADYM RF VR ICD 9250;PARADYM CRT-D 8750;PARADYM VR ICD 8250;OVATIO VR ICD 62
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

LIVANOVA CANADA CORP.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    HC