Flexitouch Plus R PD32-G3Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816305023381), received between Jan 9, 2021 and Oct 8, 2021 — classified as 3 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS SHIPPED A PD32-G3 CONTROLLER, SERIAL NUMBER (B)(6) , A FULL LEG MEDIUM LEFT GARMENT 3L-FL-MD-L LOT 645226, FULL LEG MEDIUM RIGHT GARMENT 3L-FL-MD-R LOT 644524 AND A TRUNK MEDIUM 3A-TR-MD-A LOT 21013 ON 5/19/2021. PATIENT PREVIOUSLY REPORTED PRESSURE SORE ON LEFT LATERAL FOOT AFTER USE OF THE PD32-G3 ON (B)(6) 2021. PATIENT STATED SHE HAD NOT USED THE DEVICE SINCE THE SECOND WEEK OF (B)(6) 2021 AFTER THE PRESSURE SORE WAS NOTED BY HER CLT. PATIENT REPORTED SHE WAS SEEN BY HER PCP WHO REFERRED HER TO THE WOUND CARE CLINIC. PATIENT STATED SHE CONTINUED TO HAVE A NON-HEALING PRESSURE SORE ON THE LEFT LATERAL FOOT AND WAS BEING TREATED ONCE WEEKLY IN THE WOUND CARE CLINIC. PATIENT STATED HER HCT DID NOT WANT HER TO USE THE DEVICE AND REQUESTED A RETURN. ON AUGUST 17, 2021, REGULATORY REVIEWED THE REPORTED EVENT FROM AUGUST 13, 2021 AND COMPLETED AN INVESTIGATION WITH THE RESOLUTION THAT BASED ON THE CLINICAL SERVICE INVESTIGATION, THE PRESSURE SORE COMPLAINT WAS DETERMINED TO BE AN EXACERBATED PREEXISTING CONDITION AND DID NOT MEET THE CRITERIA FOR REPORTABILITY. ON (B)(6) 2021 IT WAS REPORTED BY THE PATIENT THAT SHE HAS A POSSIBLE BONE INFECTION DUE TO A NON-HEALING PRE

  Patient problems: Impaired Healing

  MAUDE report 12600507 ↗
• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS SHIPPED A PD32-G3 CONTROLLER, SERIAL NUMBER (B)(4), A HALF LEG REGULAR LEFT GARMENT 3L-HL-RG-L LOT 117327 AND A HALF LEG REGULAR RIGHT GARMENT 3L-HL-RG-R LOT 117328 ON (B)(6) 2020. ON (B)(6) 2020 IT WAS REPORTED BY THE PATIENT'S SON THAT THE PATIENT NORMALLY HAS SHORTNESS OF BREATH BUT IT HAS BEEN WORSE WITH USE OF THE PD32-G3. TACTILE MEDIAL ADVISED THE PATIENT NOT USE THE PD32-G3 UNTIL APPROVED BY THE PATIENTS HCT. ON (B)(6) 2020 TACTILE MEDICAL FOLLOWED UP WITH THE PATIENT AND SPOKE TO THE PATIENTS SON WHO STATED THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020 AND TREATED FOR A PULMONARY EMBOLISM AND WAS DISCHARGED HOME ON (B)(6) 2020 WITH OXYGEN AND HOME NURSING / THERAPY SERVICES (NOTE: TACTILE MEDICAL HAS BEEN COMMUNICATING WITH TWO DIFFERENT FAMILY MEMBERS: ONE FAMILY MEMBER REPORTED PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2020 FOR BLOOD CLOTS IN LUNGS. SECOND FAMILY MEMBER STATED THIS TOOK PLACE ON (B)(6) 2020). PER THE PATIENTS SON, THE MD'S HAVE INSTRUCTED THE PATIENT TO HOLD USE OF THE PD32-G3 AT THIS TIME BUT THEY "DID NOT KNOW WHAT THE EMBOLISM IS FROM".

  Patient problems: Pulmonary Embolism

  MAUDE report 11174946 ↗
• InjuryJan 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS SHIPPED A PD32-G3 CONTROLLER, SERIAL NUMBER (B)(4), A FULL LEG MEDIUM LEFT GARMENT 3L-FL-MD-L LOT 117609 AND A FULL LEG MEDIUM RIGHT GARMENT 3L-FL-MD-R LOT 117499 ON (B)(6) 2020. ON DECEMBER 10, 2020 TACTILE MEDICAL RECEIVED A COMPLETED SURVEY FROM THE PATIENT THAT STATED AFTER USING THE MACHINE 2 TIMES, THE RIGHT ANKLE WAS FRACTURED IN 2 PLACES WHILE MACHINE WAS IN USE, PATIENT WENT TO HOSPITAL AND RECEIVED REHAB. ON DECEMBER 11, 2020 CLINICAL SERVICES TALKED TO THE PATIENT AND THEY STATED THEY HAD A DEMO OF THE DEVICE AND IT WORKED FINE. THEY STATED WHEN THEY WENT TO USE THE DEVICE AT HOME IT FRACTURED THEIR ANKLE IN 2 PLACES. THE PATIENT WENT TO (B)(6) HOSPITAL IN (B)(6), AT THE HOSPITAL THE PATIENT WAS GIVEN A HARD CAST. THE PATIENT WAS REFERRED TO AN ORTHOPEDIC SURGEON WHO THEY SAW TWICE. THEY SAID THE PODIATRIST WHO PRESCRIBED THE FLEXITOUCH HAS NOT BEEN TOLD ABOUT THIS INCIDENT, AND THEY HAVEN'T SEEN HIM SINCE IT WAS PRESCRIBED.

  Patient problems: Bone Fracture(s)

  MAUDE report 11143802 ↗