Bivona Trach Tube Recall Lawsuit Claims Device Failure Resulted in Child’s Death

More than a year after the girl’s death, manufacturer recalled Bivona tracheostomy tubes, due to reports that linked the devices to numerous injuries.

The parents of a 5-year-old girl from England have filed a product liability lawsuit, indicating that a recalled Bivona pediatric tracheostomy tube catastrophically failed while the child slept, causing fatal injuries.

Selma Akhtar and Kamran Mehram brought the complaint (PDF) in the U.S. District Court for the Central District of California on May 7, pursuing wrongful death and survival claims over the death of their daughter, Umaima Mehram.

The lawsuit names ICU Medical Inc. as the defendant, which took over as the manufacturer of Bivona tracheostomy tubes following the company’s 2022 acquisition of Smiths Medical. The case was removed to the U.S. District Court for the Central District of California on May 15.

Akhtar and Mehram contend that their daughter, Umaima, depended on a Bivona FlexTend 3.5 uncuffed pediatric tracheostomy tube to receive life-sustaining ventilation while sleeping and napping. However, a product defect eventually caused the tube to become dislodged, leaving her without oxygen for nearly an hour before she ultimately died from severe brain injuries

Bivona Tracheostomy Tube Recall

Bivona tracheostomy tubes are silicone airway devices used in children and adults who require long-term breathing support through a surgically created opening in the neck. The tubes are designed to remain securely in the airway through a flange that rests against the patient’s neck and is attached to ties that keep the device in place.

However, Smiths Medical initiated a worldwide recall of dozens of Bivona neonatal, pediatric and adult tracheostomy tubes on May 31, 2024, after identifying manufacturing defects that could cause the flange to crack, tear or separate. These defects could result in airway dislodgement and potentially life-threatening loss of ventilation. As of the recall notice, ICU Medical had received at least 35 reports of serious injuries and one death associated with the affected devices.

The complaint notes that the same size 3.5 pediatric FlexTend model used by Umaima was specifically included in the recall.

Tracheostomy Tube Wrongful Death Allegations

According to the complaint, Umaima was born with complex heart and airway abnormalities, forcing her to rely on a tracheostomy tube since infancy. By late 2022, her condition had improved substantially, and doctors were optimistic that she might eventually be weaned off mechanical ventilation altogether.

However, the lawsuit indicates that the Bivona tracheostomy tube Umaima used had the same defective securement flange issue described in the company’s May 2024 recall announcement.

The flange is designed to hold the tube in place. In Umaima’s case, the lawsuit alleges that it sheared away from the tube body on the morning of December 9, 2022, causing an accidental decannulation that cut off her airway.

Although her mother immediately began CPR and emergency responders were able to restore a weak pulse after 58 minutes, Umaima allegedly suffered irreversible hypoxic brain damage and died at Birmingham Children’s Hospital on January 3, 2023.

The lawsuit indicates that ICU Medical acquired Smiths Medical in January 2022, assuming responsibility for the design, manufacture and distribution of Bivona tracheostomy tubes. The complaint also alleges that the company inherited longstanding regulatory concerns, including a 2021 FDA warning letter citing deficiencies in complaint handling and corrective action procedures.

The two parents claim Umaima’s mother repeatedly reported defects involving her daughter’s Bivona tubes throughout 2022, including a protruding spring wire and multiple cracks in the connection between the securement flange and tube body. Medical staff allegedly submitted formal complaints to ICU Medical and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency, yet the company failed to act with sufficient urgency.

“At all times relevant to this action, ICU Medical misrepresented the safety of its tracheostomy tubes and securement flanges and negligently manufactured, marketed, advertised, promoted, and sold its tracheostomy tubes.”

— Selma Akhtar et al. v. ICU Medical Inc.

The filing indicates that ICU Medical’s own internal investigation identified several potential manufacturing failures. Those included an undocumented practice in which workers allegedly used scissors to cut defective flange components before returning them to production. The investigation also identified worn molds that may have created sharp edges capable of damaging the silicone flanges.

Akhtar and Mehram raise allegations of strict products liability, manufacturing defect, failure to warn, negligence, breach of express and implied warranties, wrongful death and survival action. They are seeking general, special and statutory damages.

Sign up for more legal news that could affect you or your family.