Flexitouch Plus PD32-G3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816305021400), received between Aug 10, 2020 and Nov 21, 2024 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS PRESCRIBED A PD32-G3 PNEUMATIC COMPRESSION DEVICE FOR TREATMENT OF LOWER EXTREMITY LYMPHEDEMA AND RECEIVED THE DEVICE ON (B)(6) 2021. ON (B)(6) 2024, THE PATIENT CONTACTED TACTILE MEDICAL AND SPOKE WITH CLINICAL PATIENT SERVICES REPORTING THE HOSE ON THE LEFT LEG GARMENT CAUSED A LARGE WOUND. HE STATED THAT HE HAD NOT USED THE DEVICE BETWEEN 2021, AFTER INITIALLY RECEIVING THE DEVICE, AND ON (B)(6) 2024. NO REASON WAS GIVEN FOR THE PAUSE IN USAGE. THOUGH DURING THIS TIME, HE HAD VARIOUS VASCULAR PROCEDURES AND A RIGHT LEG AMPUTATION. WITH CLEARANCE AND OVERSIGHT OF HIS TREATING CLINICIAN, THE PATIENT RESUMED USE OF DEVICE ON (B)(6) 2024, THREE TIMES PER WEEK WITH ASSISTANCE OF A HOME HEALTH AIDE. HE HAD SEVERAL COMORBIDITIES INCLUDING WOUNDS, HEEL TRAUMA, AND DVT OF LEFT LOWER EXTREMITY BEING MEDICALLY MANAGED. A HOME HEALTH AIDE ASSISTED WITH DEVICE USAGE AND APPLICATION OF GARMENT, WHICH PATIENT NOTED THEY FELT WAS BEING WRAPPED TIGHTLY, OVER TWO-LAYER BANDAGING, FOAM PADDING AND KOBAN FROM TOES TO KNEE ON LEFT LEG. DUE TO PARAPLEGIA, THE LEFT LEG EXTERNALLY ROTATED TOWARD THE HOSES WITHIN THE GARMENT. THE PATIENT REPORTED HE HAS NO SENSATION IN HIS LEFT LEG, THUS

  Patient problems: Impaired Healing

  MAUDE report 20751762 ↗
• InjuryAug 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECEIVED A PD32-G3 CONTROLLER, SERIAL NUMBER (B)(4); A FULL LEG SHORT LEFT GARMENT 3L-FL-SH-L LOT 20027; A FULL LEG SHORT RIGHT GARMENT 3L-FL-SH-R LOT 20006 AND A TRUNK SMALL 3A-TR-SM-A LOT 603250 ON (B)(6) 2020 AND BEGAN USING IT ON (B)(6) 2020. PATIENT PERFORMED PRESCRIBED PROTOCOL OF L1, BILATERAL SIMULTANEOUS LOWER EXTREMITY TREATMENT WITH NORMAL PRESSURE, ONE TIME PER DAY. DURING THE FIRST WEEK OF (B)(6) 2020, PATIENT REPORTED FEELING SYMPTOMS OF SLUGGISHNESS AND SHORTNESS OF BREATH. PATIENT STATED, ON (B)(6) 2020 THEY CAME UP FROM THEIR BASEMENT AND COULD NOT CATCH THEIR BREATH WHICH LED THEM TO GO THE EMERGENCY DEPARTMENT AT DOCTOR'S COMMUNITY HOSPITAL, (B)(6) WHERE THEY WERE THEN ADMITTED. PATIENT DISCHARGED TO HOME ON (B)(6) 2020. THE PATIENT WAS DIAGNOSED WITH BILATERAL PE BLOOD CLOTS AND A DEEP VEIN THROMBOSIS BEHIND THE KNEE IN THE POPLITEAL REGION OF THE RIGHT LOWER EXTREMITY. THE PATIENT WAS PRESCRIBED ANTICOAGULATION THERAPY FOR A MINIMUM OF THREE MONTHS. WHILE AT THE EMERGENCY DEPARTMENT, PATIENT WAS DIAGNOSED AND TREATED BY DR. (B)(6), EMERGENCY MEDICINE MD, (B)(6). THE PATIENT'S PCP, DR. (B)(6), INTERNIST, IS THE PRESCRIBER OF THE PRODUCT. THE PATIENT

  Patient problems: Thrombosis

  MAUDE report 10388789 ↗