FDA Sounds Alarm After 33 Injuries Tied To Medtronic Device Malfunction

The U.S. Food and Drug Administration (FDA) is aware that Medtronic Plc MDT and its subsidiary, Given Imaging Inc., have issued two letters to affected customers recommending that certain Bravo CF Capsule Delivery Devices be removed from where they are used and sold.

What Happened: Earlier in June, Medtronic sent all affected customers an "URGENT: MEDICAL DEVICE RECALL" letter. An updated letter was sent on June 16.

Medtronic on Tuesday stated that the capsule may not attach to the patient's esophagus or detach from the delivery device as intended due to a misapplication of the adhesive during manufacturing the Bravo CF capsule delivery device.

Risks associated with this issue include patient aspiration/inhalation, perforation of the esophagus, airway obstruction, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.

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Why It Matters: Medtronic has reported 33 serious injuries and no deaths associated with this issue.

The Bravo system is designed to place and attach a pH monitoring capsule to the esophagus, recording pH data to assist a physician in diagnosing clinical gastroesophageal reflux.

The Bravo system involves placing a pH capsule against the mucosal wall of the esophagus, simultaneously measuring pH, and transmitting the data to a recorder attached to the patient's waist.

The patient interacts with the recorder to indicate symptoms, allowing the physician to compare the patients' symptoms to the occurrence of the reflux episodes.

Additionally, on Monday, the FDA said that Medtronic’s subsidiary, Medline Industries, LP, sent all affected customers an Immediate Action Required Medical Device Recall notice in February.

Medline Industries LP is correcting certain lots of their medical procedure kits containing recalled Medtronic Aortic Root Cannulas due to the potential for excess material in the male luer. 

Medline is providing a sticker to attach to the procedure kits, notifying the user not to use the aortic root cannula within the procedure kit and to use an aortic root cannula from another supplier.

The use of the affected products may cause serious adverse health consequences, including procedure delay, neurological deficits/stroke (reversable and irreversible), and death.   

 At this time, Medline Industries has reported no serious injuries or deaths related to this issue.

Medline medical procedure kits containing Medtronic Aortic Root Cannulas are convenience kits used for various medical procedures.

The Medtronic Aortic Root Cannula in the kit is used for six hours or less during surgery with the heart-and-lung machine (cardiopulmonary bypass). The cannula may also be used to remove air from the major artery (aorta) when a bypass procedure is finished.

Price Action: MDT stock is up 0.3% at $86.36 at the last check on Wednesday

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