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Medtronic's StealthStation Feature Recall Classified Class I

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FDA has classified the recent recall of Medtronic's (MDT - Free Report) StealthStation auto-registration feature for deep brain stimulation (DBS) procedures as Class I due to health risks associated with its use. However, the products will remain on the market for now.

In August 2019, Medtronic had sent Urgent Medical Device Correction letters to all affected customers. The letter advised the healthcare providers to gauge the benefits versus risks of fiducial-based or fiducial-less registration methods and provided additional instructions for navigational accuracy and better functionality during the procedure.

Reason Behind the Recall

Medtronic had to announce the recall of the auto-registration feature on the StealthStation DBS Software due to some malfunctioning caused by the device during a DBS procedure. More specifically, there were inaccuracies caused by minor patient movements during the auto-registration process when used with NexFrame Stereotactic System (Medtronic’s stereotactic frame using StealthStation navigation).

This fault may remain unnoticed by the surgeon or the device system. This may lead to flawed registration data and thereby may direct surgeons to inaccurately navigate lead placement during image guided DBS procedures. Per the FDA, this could result in serious or life-threatening situations.

As of the end of June 2020, 33 medical device reports were identified out of which 22 were related to device malfunction and 11 related to injuries.

Recalls Continue for StealthStation

This is not the first time, Medtronic’s StealthStation surgical navigation system is facing product recall issue. In January 2019, the FDA announced that Medtronic had recalled its Synergy Cranial Software and StealthStation S7 Cranial Software used with the StealthStation Surgical Navigation System due to reports of incorrect information displayed during biopsy procedures. FDA had identified this recall too as Class I.

The company is currently dealing with an obligation under the FDA consent decree entered in April 2015 relating to the SynchroMed drug infusion system and the Neuromodulation quality system.

Share Price Performance

Over the past six months, Medtronic has underperformed the industry it belongs to. The stock has declined 8.82% compared with the industry's 1.3% fall.

Zacks Rank & Key Picks

Currently, Medtronic carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are Aphria Inc. , Illumina, Inc. (ILMN - Free Report) and QIAGEN N.V. (QGEN - Free Report) .

Aphria’s long-term earnings growth rate is projected at 24.6%. It currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Illumina’s long-term earnings growth rate is estimated at 11%. The company presently has a Zacks Rank #2.

QIAGEN’s long-term earnings growth rate is estimated at 12.2%. It currently sports a Zacks Rank #1.

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