Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Tactile Systems Technology medical devices: approvals, recalls and adverse events

Stock: TCMD. Includes companies and brands it has bought. Official US government data, updated September 2026.

510(k) clearances

De Novo: 0

PMA approvals

0 supplements

Recalled products

- class I

Adverse event reports

1 deaths reported

How many recalls does Tactile Systems Technology have?

Tactile Systems Technology has - recalled medical device products in - recall actions in the records, - of them class I (the most serious kind).

How many medical devices has Tactile Systems Technology had cleared or approved?

11 510(k) clearances, 0 De Novo grants and 0 original PMA approvals for high-risk devices, plus 0 PMA supplements (changes to approved devices). The newest decision was on Jul 31, 2026.

How many adverse event reports name Tactile Systems Technology devices?

26 reports in total: 1 deaths, 23 injuries and 2 malfunctions were reported. 1 reports were received in 2025. A report alone does not show that the device caused the problem.

Clearances and approvals by year

Last 15 years

Year	510(k) clearance	De Novo grant	PMA approval	PMA supplement
2026	2	0	0	0
2024	1	0	0	0
2020	1	0	0	0
2017

Newest clearances and approvals

Flexitouch® Plus Advanced Pneumatic Compression System
K253555 · 510(k) clearance · Jul 31, 2026
AffloVest® Mobile Airway Clearance Therapy
K252849 · 510(k) clearance · Apr 30, 2026
Nimbl (model PD08-N1)
K234155 · 510(k) clearance · Jun 21, 2024
Flexitouch Plus System
K203178 · 510(k) clearance · Dec 20, 2020
Flexitouch System
K170216 · 510(k) clearance · May 26, 2017
Flexitouch System
K153311 · 510(k) clearance · Sep 14, 2016
entré Model PD08-U
K143185 · 510(k) clearance · May 7, 2015
ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM
K131193 · 510(k) clearance · Jun 18, 2013
FLEXITOUCH SYSTEM
K120972 · 510(k) clearance · Apr 13, 2012
FLEXITOUCH SYSTEM
K062818 · 510(k) clearance · Oct 6, 2006
BIOTOUCH MASSAGE THERAPY SYSTEM
K013061 · 510(k) clearance · Jul 1, 2002

Devices with the most adverse event reports

By product code, all years

Sleeve, Limb, Compressible (JOW, class 2)18
Massager, Powered Inflatable Tube (IRP, class 2)7
Percussor, Powered-Electric (BYI, class 2)1

All device makers and procedures · TCMD stock page

Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to TCMD with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.