Bivona Flange Defect Lawsuit: ICU Medical Claims and Recall

The Bivona flange defect lawsuit is a wrongful death case filed in May 2026 by the parents of a five-year-old girl who died after the securement flange on her Bivona pediatric tracheostomy tube sheared away from the tube body, dislodging the device and cutting off her airway. The suit, Akhtar v. ICU Medical, is pending in the U.S. District Court for the Central District of California and accuses ICU Medical of knowing about the flange defect well before it recalled the tubes in May 2024.¹

How the Flange Defect Causes Harm

The securement flange on a Bivona tracheostomy tube is the flat piece that sits against the patient’s neck and holds the silicone tube in position inside the trachea. Smiths Medical, which manufactured the Bivona line before ICU Medical acquired it in 2022, determined that a manufacturing defect in certain lots could cause the flange to tear, crack, or separate from the tube shaft. When that happens, the tube can shift out of place or fall out entirely, and the patient cannot breathe.²

The FDA classified the recall as Class I, its most serious category, and by late 2024 the agency had linked the defect to 35 reported injuries and two deaths.³

What Happened to Umaima Mehram

Umaima Mehram was born with complex heart and airway abnormalities that required a tracheostomy tube from infancy. By late 2022, at five years old, she had been improving, and her doctors were reportedly optimistic about eventually weaning her off mechanical ventilation.¹

On December 9, 2022, while she was sleeping, the securement flange on her Bivona FlexTend 3.5 uncuffed pediatric tracheostomy tube sheared away from the tube body, according to the complaint. The tube dislodged and she went without oxygen for close to an hour. The resulting hypoxic brain damage was irreversible, and Umaima died on January 3, 2023, at Birmingham Children’s Hospital.¹

The Claims Against ICU Medical

Selma Akhtar and Kamran Mehram filed suit on May 7, 2026, and the case was removed to federal court on May 15, 2026. The complaint pursues claims for wrongful death, survival action, strict products liability, manufacturing defect, failure to warn, negligence, and breach of express and implied warranties.¹

The factual allegations go beyond the defect itself. According to the complaint, workers on the production line engaged in an undocumented practice of using scissors to trim defective flange components before returning them to production. Internal investigations reportedly revealed worn manufacturing molds that created sharp edges capable of compromising the silicone flanges. The plaintiffs also allege the company received multiple reports of flange defects during 2022, including cracks in the securement flange and protruding spring wires, but did not act with sufficient urgency.¹

The complaint points to an October 2021 FDA warning letter to Smiths Medical’s Minneapolis facility as evidence of longstanding quality-system problems that ICU Medical inherited when it acquired Smiths Medical in 2022. FDA inspectors had found that complaints received through a support helpline were tracked only in emails rather than in the official complaint management system, that several corrective-action investigations tied to deaths and serious injuries had been left open, and that the company lacked standardized criteria for deciding when events had to be reported to the agency.⁴

Why the Recall Timing Matters

Smiths Medical did not issue its Urgent Medical Device Notification until May 29, 2024, roughly seventeen months after Umaima’s death. The notification instructed healthcare facilities to check inventory, stop using affected products, and discard them, and it covered a broad range of neonatal, pediatric, and adult Bivona models, including the FlexTend line involved in Umaima’s case.² That gap between the alleged internal knowledge of defects in 2022 and the public recall in 2024 anchors the failure-to-warn theory in the complaint.

Earlier Adverse-Event Reports

Flange-integrity problems appeared in the FDA’s MAUDE database before the recall. A September 2020 report described a customized Bivona tube whose cuff broke away from the shaft and whose flange tore away from the right side of the tube; the failure was caught at the end of therapy and no patient injury was reported.⁵

A March 2024 report described a patient who experienced decannulation and cardiorespiratory arrest lasting approximately five minutes after the tube’s balloon appeared inflated but had actually deflated, allowing the cannula to dislocate. The patient required resuscitation and hospital admission, and the report noted it was the second time the same patient had experienced the problem. The manufacturer said no product sample was returned for evaluation and the failure mode could not be confirmed.⁶

Are There Other Bivona Lawsuits?

The Akhtar case is the most detailed lawsuit to emerge publicly, but it is not the only legal activity around the recall. At least one firm, Robins Kaplan, opened a mass-tort investigation into Bivona flange defects after the recall, though it later stopped accepting new inquiries. Other firms have continued to solicit clients who were injured or who lost family members due to the flange defect. As of mid-2026, no multidistrict litigation or formal class action has been established in connection with the Bivona flange defect, and the Akhtar case remains in its early stages in the Central District of California.¹

1
AboutLawsuits.com. Bivona Trach Tube Recall Lawsuit: Device Failure Linked to Child’s Death
2
U.S. Food and Drug Administration. Tracheostomy Tube Recall: Smiths Medical Removes Certain Bivona Neonatal/Pediatric and Adult
3
FDA Enforcement Reports. Recall Z-2601-2024, Bivona AireCuf TTS FlexTend
4
U.S. Food and Drug Administration. Warning Letter: Smiths Medical ASD Inc., CMS 617147
5
FDA MAUDE Database. MAUDE Report 3012307300-2020-09926
6
FDA MAUDE Database. MAUDE Report 9617604-2024-00856