The Implant Files -
International Medical Devices Database
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Recall of Device Recall ActiveCare DVT
According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medical Compression 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
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Event ID
59812
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Event Risk Class
Class 2
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Event Number
Z-0387-2012
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Event Initiated Date
2011-08-28
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Event Date Posted
2012-01-11
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Event Status
Terminated
- Event Country
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Event Terminated Date
2012-07-11
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Event Source
USFDA
- Event Source URL
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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
Sleeve, limb, compressible - Product Code JOW
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Reason
This voluntary field action is being undertaken because mcs has received a limited number of reports involving the use of a non-mcs ac/dc adaptor with the activecare dvt and activecare+s.F.T. devices. the firm found that an activecare dvt device may work improperly if connected to a non-mcs ac/dc adaptor with a higher nominal voltage. as specified in each product's user manual, the activecare dvt.
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Action
Medical Compression Systems (DBN) Ltd, sent out "VOLUNTARY FIELD ACTION" letters dated September 15, 2011 to all affected customers. The letter included description of the device and problem. Customers were instructed to check their inventory and make a list of serial numbers of all applicable ActiveCare+S.F.T. and ActiveCare DVT devices in their inventory, include the list on the attached excel file (Field Action Verification Form) and email to maya@mcsmed.com; even if they do not have any such devices. The letter also states that within 15 days from the email, they will receive instructions for the next steps. In addition, the letter stated -YOU MAY CONTINUE TO USE THE ActiveCare+S.F.T.¿ DEVICES WHILE AWAITINGTHE INSTALLATION OF THE OVP. In case you have questions or you need any assistance, you can contact the firm at (317) 485-7887 or e-mail to: maya@mcsmed.com or mahlet@mcsmed.com.
Device
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Model / Serial
Device Catalog Number A502B-0001-02 and H502B-0001-07
- Product Classification
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Device Class
2
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Implanted device?
No
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Distribution
Nationwide distribution.
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Product Description
ActiveCare DVT || Medical Compression Systems || OR Aqiva, IL || Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound healing time; treatment and assistance in healing of stasis dermatitis, venous stasis ulcers and diabetic leg ulcers; Treatment of chronic venous insufficiency and; Reducing edema
- Manufacturer
Manufacturer
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Manufacturer Address
Medical Compression Systems, 2 Hallan St, OR Aqiva Israel
- Manufacturer Parent Company (2017)
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Source
USFDA