The news comes only weeks after analysts expressed optimism that the company was moving ahead of previous regulatory challenges with the FDA.
Outset Medical (Nasdaq: OM) recalled certain Tablo hemodialysis systems after non-dioxin-like polychlorinated biphenyl acids (NDL-PCBAs) leaching was identified at levels above allowable safety limits. Peroxide-cured silicone tubing in the machines’ hydraulics and dialysate lines caused the unsafe NDL-PCBAs levels.
The dialysate solution may expose patients to higher than allowable limits. According to the FDA, Outset Medical determined that leaching NDL-PCBAs decreases over time and will reduce to an acceptable safety level after 336 hours of console operational use.
Exposure to NDL-PCBAs and NDL-PCBA-related compounds can potentially cause serious adverse health consequences months to years after exposure. It can lead to endocrine dysfunction, liver issues, neurobehavioral changes, skin problems and male infertility.
The recall is to replace the tubing on consoles with less than 336 hours of use. There have been no reports of injuries or deaths related to this issue.
This recall may affect patients receiving dialysis with the Tablo and those who may receive care using the system in the future. Healthcare providers who use the Tablo to care for patients are also affected.
Outset Medical’s remediation
Outset Medical issued an urgent medical device correction letter on March 6, warning customers that non-dioxin-like NDL-PCBAs could leach from the system and into patients at unsafe levels. In the letter, the company recommended using alternative machines if any are available. It said if the Tablo is the only available option, continue to use them so that patients can continue to have access to dialysis treatment until the devices are serviced.
The company also recommended examining inventory to confirm device serial numbers as identified in the letter. The FDA said devices starting with serial number 604572M were manufactured with platinum-cured tubing and are not affected.
Tablo’s rocky path
In June 2022, Outset put a hold on shipments of the Tablo hemodialysis system for home use. The hold came as a result of a pending FDA review and clearance of a 510(k) submitted for changes made since the Tablo system’s original March 2020 clearance. By August 2022, the company had received the 510(k) clearance and resumed Tablo shipments.
But more than a year later — in July 2023 — Outset Medical received an FDA warning letter for the Tablo. The FDA said certain materials it reviewed on Outset’s website promote continuous renal replacement therapy (CRRT), which falls outside the current indications for the Tablo hemodialysis system. Outset said it believes it effectively addressed this concern through labeling and promotional changes already underway.
However, analysts opened coverage on Outset Medical earlier this month with significant optimism around future growth for the company.
