Flexitouch PD32-URecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816305020106), received between Jul 26, 2017 and Sep 20, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Delamination” (1 report).

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.

• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FLEXITOUCH CONTROLLER, PD32-U AND RIGHT UPPER EXTREMITY (RUE) GARMENT, U-AS-S2-R, A-TR-00-A WERE ORDERED ON (B)(6) 2017 AND SHIPPED ON (B)(6) 2017. TRAINING WAS COMPLETED ON (B)(6) 2017. TRAINING WAS COMPLETED ON (B)(6) 2017. ON (B)(6) 2019 THE PATIENT CALLED TO REPORT THEY WOULD LIKE TO KNOW HOW TO USE HER FLEXITOUCH DEVICE ON HER ARM ONLY. THE PATIENT USED THE FLEXITOUCH TO MANAGE THEIR RIGHT UPPER QUADRANT LYMPHEDEMA, WHICH INCLUDED CHEST TREATMENT ON THE ORIGINAL ORDER. THE PATIENT WAS SHIPPED AND TRAINED ON THE DEVICE IN NOVEMBER 2017 AND REPORTED PAIN STARTING IN (B)(6) 2017. IN (B)(6) 2018, THE PATIENT WAS SEEN FOR FOLLOW-UP AND A CT SCAN AND AT THAT POINT THE PATIENT REPORTED THEY WERE DIAGNOSED WITH STAGE 4 METASTATIC BREAST CANCER AND HAD 7 ACUTE/CHRONIC RIB FRACTURES. THE PATIENT DID NOT REQUIRE HOSPITALIZATION OR TREATMENT FOR THE FRACTURED RIBS, THE DIAGNOSIS WAS NOT MADE UNTIL SEVERAL MONTHS AFTER THEY USED THE FLEXITOUCH AND THE RESULTING PAIN. THE FRACTURED RIBS WERE HEALED AT THE TIME OF THE CT SCAN. THE STAGE 4 METASTATIC BREAST CANCER AS WELL AS THE 7 ACUTE/FRACTURED RIBS WERE DIAGNOSED WITH A CT SCAN IN (B)(6) OF 2018; THE PT DISCLOSED THIS INFORMATION TO TACT

  Patient problems: Bone Fracture(s)

  MAUDE report 9099849 ↗
• InjuryJan 26, 2018Improper or Incorrect Procedure or Method

  PATIENT IS A (B)(6) MALE, (BMI 52.9) WITH BILATERAL LOWER EXTREMITY LYMPHEDEMA. ON (B)(6) 2017, HIS PHYSICIAN PRESCRIBED PNEUMATIC COMPRESSION TREATMENT FOR USE IN THE HOME TO TREAT HIS CHRONIC LYMPHEDEMA. APPARENTLY, NO DUPLEX EXAMINATION WAS PERFORMED TO RULE OUT VENOUS DISEASE IN THIS MORBIDLY OBESE MAN WITH A FAMILY HISTORY OF THROMBO-EMBOLIC DISEASE.THE PRESCRIPTION INDICATES THAT THE PATIENT HAD NO CURRENT CONTRAINDICATIONS PRECLUDING TREATMENT. THE PHYSICIAN REQUESTED THAT THE PATIENT RECEIVE A DEMONSTRATION OF THE EQUIPMENT. THE DEMONSTRATION WAS CONDUCTED, WITHOUT INCIDENT, ON (B)(6). THE DEMONSTRATION DOCUMENTATION REFLECTS THAT THERE WERE NO CURRENT CONTRAINDICATIONS. THE MANUFACTURER SHIPPED THE DEVICE ON (B)(6); THE PATIENT WAS TRAINED BY A CLINICIAN IN THE HOME ON (B)(6) 2017. THE TRAINING SESSION WAS UNEVENTFUL. THE NEXT MORNING, THE PATIENT FELT FATIGUED BUT CONDUCTED HIS TREATMENT. PATIENT CONTINUED TO FEEL UNWELL AND HAD INCREASED DIFFICULTY WITH MOBILITY AFTER TREATMENT. BY THAT EVENING, PATIENT EXPERIENCED DYSPNEA AND DIAPHORESIS. THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS FOUND VIA X-RAY TO HAVE A LARGE SADDLE PULMONARY EMBOLISM. THE PATIENT WAS ADMITTED TO

  Patient problems: Pulmonary Embolism

  MAUDE report 7222614 ↗
• InjuryJul 26, 2017Delamination; Delamination

  THE PATIENT HAS A HISTORY OF LEFT BREAST CANCER RESULTING IN MASTECTOMY, LYMPH NODE REMOVAL, RADIATION AND CHEMOTHERAPY WITH DIAGNOSIS OF POST-MASTECTOMY LYMPHEDEMA SYNDROME. PATIENT IS UNDERGOING BREAST RECONSTRUCTION AND AT THE TIME OF THE EVENT HAD A BREAST TISSUE EXPANDER IN PLACE AS PART OF HER PHASE ONE BREAST RECONSTRUCTION. PATIENT WAS DIAGNOSED WITH POST-MASTECTOMY LYMPHEDEMA IN HER LEFT ARM AND CHEST. PT WAS PRESCRIBED THE PNEUMATIC COMPRESSION DEVICE AS PART OF HER LYMPHEDEMA TREATMENT. PT RECEIVED THE DEVICE ON (B)(6) 2017 AND WAS TRAINED ON IN THE ON (B)(6) 2017. PATIENT USED THE DEVICE DAILY AS PRESCRIBED WITHOUT INCIDENT FOR APPROXIMATELY 10 WEEKS. ON (B)(6), THE PATIENT NOTICED HER LEFT BREAST APPEARED SMALLER. TWO DAYS LATER, THE SURGEON RE-FILLED THE TISSUE EXPANDER (MENTOR #(B)(4)). THE TISSUE EXPANDER AGAIN DEFLATED THE NEXT DAY. THE DECISION WAS MADE TO EXPEDITE THE SURGICAL REMOVAL OF THE EXPANDER AS IT APPEARED TO HAVE A LEAK. THERE WERE NO FURTHER REPORTED COMPLICATIONS. THE PATIENT WILL UNDERGO BREAST RECONSTRUCTION SURGERY AS PLANNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6745203 ↗