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Medical device recall
November 23, 2022
Medical device recall

Baxter Recalls WatchCare IMS Due to Risk of Interference with Nearby Medical Equipment 

By MedTech Intelligence Staff
No Comments

Baxter Hillrom is recalling its WatchCare Incontinence Management System (IMS) following reports that the radiofrequency emissions (RF) from WatchCare devices may interfere with other medical devices.

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Medical device recall
June 8, 2022
Medical device recall

Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect

No Comments

An analysis of the HVAD pump implant kit showed moisture had entered the center post of the pump causing corrosion and demagnetization of the internal magnets, which may cause the pump to rotate incorrectly.

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FDA
March 9, 2022
FDA

FDA’s Final Guidance Pushes Companies to be Recall Ready

By MedTech Intelligence Staff
No Comments

The agency is urging manufacturers to not only have recall policies in place before a recall is necessary, but to also act quickly in initiating a recall when public health is at risk.

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Medical device recall
August 21, 2017
Medical device recall

Cook Medical Recalls Zenith Endovascular Graft

By MedTech Intelligence Staff
No Comments

In the United States, nearly 4500 devices will be relabeled and 500 devices removed due to the risk of thrombus formation in the device.

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Alert
August 14, 2017
Alert

Following Reported Deaths, FDA Issues Alert on Intragastric Balloons

By MedTech Intelligence Staff
No Comments

The agency has alerted healthcare providers of unanticipated deaths related to the systems intended to treat obesity.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
August 9, 2017
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Is Dr. D on Your Approved Supplier’s List?

By Dr. Christopher Joseph Devine
1 Comment

Device establishments must maintain records of acceptable suppliers.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
July 17, 2017
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

No Control

By Dr. Christopher Joseph Devine
No Comments

Although not always subject to receiving inspection, defining control of non-inventory items, such as manufacturing materials, is critical.

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CARDIS device
July 11, 2017
CARDIS device

Diagnose Heart Disease in One Click

By MedTech Intelligence Staff
No Comments

European scientists have developed a handheld scanner that works similar to a supermarket scanner for early detection of cardiovascular disease.

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Cybersecurity
June 27, 2017
Cybersecurity

Side Effects: Cybersecurity and Medical Device Recalls

By Chris Harvey
No Comments

When a software patch or device update cannot remedy a cyber threat, sometimes a recall is necessary.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
June 12, 2017
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Recall, That Nasty 6-Letter Word!

By Dr. Christopher Joseph Devine
No Comments

This offending company has “significant” violations regarding reporting corrections and removals to FDA.

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