FDA Medical Device Recall

Outset Medical, Inc. Recalls Certain Tablo Hemodialysis Systems for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBAs

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.

The devices described in this recall are related to the ongoing evaluation announced in the Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – Letter to Health Care Providers.

Please be aware, this recall is a correction, not a product removal.

KCER Release Date: April 25, 2024

To: KCER Distribution list- including ESRD Network EDs and QIDs

Recalled Product 

• Product Name: Tablo Hemodialysis Device

• Product Codes: See Recall Database Entry 

• Devices Recalled in the U.S.: 879 

• Dates Distributed: August 25, 2018 to December 4, 2023

• Date Initiated by Firm: March 6, 2024

Device Use

The Tablo Hemodialysis System is for use in patients with acute kidney failure, or chronic kidney failure, or both.  The system is used in health care facilities or in home settings by individuals trained in the use of the system. The Tablo Hemodialysis System functions as an artificial kidney system and can provide the following treatment types: intermittent hemodialysis (IHD), sustained low efficiency dialysis (SLED/ SLEDD), prolonged intermittent renal replacement therapy (PIRRT), and isolated ultrafiltration. 

Reason for Recall

Outset Medical, Inc., is recalling certain Tablo Hemodialysis System after non-dioxin-like polychlorinated biphenyl acids (NDL-PCBAs) leaching were identified at levels above allowable safety limits. The NDL-PCBAs are coming from the peroxide cured silicone tubing used as a part of the machine’s hydraulics and for the dialysate lines. Patients may be exposed to higher than allowable limits of these NDL-PCBA compounds via the dialysate solution. 

Outset Medical, Inc., determined that NDL- PCBAs leaching decreases over time, and that NDL-PCBAs reduce to an acceptable safety level after 336 hours of console operational use. This recall is aimed at changing the affected tubing for consoles that have been in use for less than 336 hours.

NDL-PCBAs are an acid of NDL-PCBs. Exposure to NDL-PCBs or NDL-PCB related compounds may cause serious adverse health consequences months to years after exposure, including endocrine dysfunction, liver issues, neurobehavioral changes, skin problems (acne, rashes), and male infertility.

Outset Medical, Inc., reports no injuries or deaths related to this issue. 

Who May be Affected

• Patients who currently receive dialysis with the Tablo Hemodialysis System and those who may receive care using the system in the near future.  

• Health care providers who use the Tablo Hemodialysis System to care for patients. 

What to Do

On March 6, 2024, Outset Medical, Inc., issued an Urgent Medical Device Correction letter informing customers that non-dioxin-like NDL-PCBAs could leach from the system into patients at higher than allowable levels. The letter also recommended the following actions for customers/users:

• If you have new Tablo Hemodialysis System(s), consider using other alternative machines, if any are available. If you only have new Tablo Hemodialysis Systems available to use, continue to use them so that your patients have access to dialysis treatment, until the devices are serviced.

• Examine inventory to confirm device serial numbers as identified in the letter. Devices starting with serial number 604572M were manufactured with platinum-cured tubing and are not affected. 

• Disseminate this information to appropriate personnel within the facility for processing and distribution. 

• Share the notice with any organization where the potentially affected devices have been transferred. 

• Identify and notify any home patients who may have received affected product. 

• Complete the acknowledgement and receipt form enclosed with the letter and promptly return it to Outset. 

Contact Information

Customers with questions should contact Outset’s Technical Support team (844-MYTABLO or 844-698-2256).

Additional Resources: 

• Medical Device Recall Database Entry

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.