Recalls: Centurion Medical's Airway Kit with Sheridan Endotracheal Tubes & Abbott’s Ellipse Implantable Cardio Defibrillators

Aug. 6, 2019

Teleflex informed Centurion of its recall for select Sheridan Endotracheal Tubes and Connectors, as Centurion includes the recalled product in their convenience kit, according to Safety Communication from the Food and Drug Administration. Teleflex recalled multiple models of the Hudson RCI Sheridan and Sheridan Endotracheal Tubes due to reports of the Sheridan endotracheal tube connector dislodging from the endotracheal tube, causing disconnection of the patient from the breathing circuit, which may result in insufficient oxygenation, decrease in vital signs, or death.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Four deaths and 18 injuries have been reported to Teleflex in association with disconnection. However, Centurion has no reported injuries or complaints.

The airway kits contain endotracheal tubes to open the patient’s airway, provide ventilation, and administer anesthetic gas when a patient cannot maintain adequate respiratory function to meet their needs, such as while under general anesthesia during a surgical procedure.

Those who may be affected are patients who had procedures under general anesthesia from November 28, 2018, to June 5, 2019, involving Centurion’s Airway Kit containing Teleflex/Sheridan endotracheal tubes. Centurion issued a customer notification letter on July 3, 2019, to Medline, the parent company and sole customer for this product, to communicate with affected customers, instructing customers to identify affected product in inventory and return affected product.

Also, Abbott (Formerly St. Jude Medical Inc.) is recalling the Ellipse Implantable Cardioverter Defibrillators (ICDs) because electrical failures have been identified and determined to be due to a faulty manufacturing process causing some aluminum wires to be partially exposed, reports the Food and Drug Administration. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

ICDs which contain aluminum wires that are not fully insulated are prone to electrical shorting of the capacitor.  The potential patient impact could be the inability to deliver high voltage therapy. There is currently no available method or procedure to determine which of these devices have this issue prior to failure.

Abbott is aware of zero (0) related reports of this failure occurring in any affected implanted devices.  Of the devices recalled in the U.S., 31 devices have been implanted. The complaints and MDRs available have either reported that the affected devices have been replaced or are scheduled to be replaced with another ICD generator. None of the complaint or MDRs indicate that any patient harm or adverse events have occurred, and no deaths have been reported.

Abbott implantable cardioverter defibrillators provide pacing for slow heart rhythms and electrical shock or pacing to stop dangerously fast heart rhythms. These cardiac devices are implanted under the skin in the upper chest area with connecting insulated wires called "leads" that go into the heart. A patient may need an implantable cardiac device if their heartbeat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure.

On June 21, 2019, Abbott hand-delivered an Urgent Medical Device Recall letter to customers. The letter directed customers to take the following actions:

· Review the device model and serial numbers to identify the impacted patients and return the acknowledgement form to the sales representative.

· Device explant and replacement are recommended. Abbott will work with you to provide an Abbott replacement device.