Invia Motion Endure 200.8587Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07612367052849), received between Jan 7, 2019 and Mar 31, 2020 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K161128, K172145); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2020Nonstandard Device; Loss of Power; Charging Problem

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE MOTION NEGATIVE PRESSURE WOUND THERAPY DEVICE WAS NOT HOLDING A CHARGE AND WHEN SHE UNPLUGGED IT, IT WOULD TURN OFF. ADDITIONALLY THE CUSTOMER REPORTED THAT THERE WERE NO LEAKS IN THE SYSTEM WHILE ON THE PATIENT; THERE WAS NO SERIOUS INJURY; THE PATIENT DID NOT EXPERIENCE WOUND DETERIORATION AND THE PATIENT DID NOT REQUIRE CONSULTATION AND/OR TREATMENT BY A MEDICAL PROFESSIONAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9903303 ↗
• InjuryOct 22, 2019Defective Alarm; Obstruction of Flow

  ON (B)(6) 2019, A CUSTOMER ALLEGED TO MEDELA LLC THAT THE MOTION DEVICE WAS NOT SIGNALING OR BEEPING TO INFORM OF A LEAK WHILE IN USE ON A PATIENT, WHO WAS BEING TREATED WITH NEGATIVE PRESSURE WOUND THERAPY FOLLOWING A TOE AMPUTATION. THE CUSTOMER FURTHER ALLEGED THAT THE DRAPE HELD THE LEAKAGE IN SO THE PATIENT WAS IN A WET DRESSING FOR TWO DAYS AWAITING HIS NEXT DOCTOR'S VISIT, WHICH RESULTED IN AN INFECTION. THE DOCTOR HAD TO DEBRIDE INTO THE BALL OF THE PATIENT'S FOOT AND, IN DOING SO, THE WOUND BECAME MUCH DEEPER/LARGER. THE PATIENT WAS SWITCHED TO A LIBERTY DEVICE BECAUSE THERE WAS TOO MUCH DRAINAGE FOR THE MOTION.

  Patient problems: Unspecified Infection

  MAUDE report 9219009 ↗
• MalfunctionApr 8, 2019Nonstandard Device; Unexpected Shutdown

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT WHEN THE MOTION NEGATIVE PRESSURE WOULD THERAPY DEVICE WAS NOT PLUGGED INTO AN ELECTRICAL OUTLET, IT POWERED DOWN AND WOULD NOT POWER BACK ON, THOUGH APPROXIMATELY 30 MINUTES LATER IT POWERED ON WITHOUT PROMPTING. THOUGH THE ISSUE OCCURRED WHILE ON A PATIENT, THERE WAS NO SERIOUS INJURY, THE PATIENT DID NOT EXPERIENCE WOUND DETERIORATION AND THE PATIENT DID NOT REQUIRE CONSULTATION AND/OR TREATMENT BY A MEDICAL PROFESSIONAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8491395 ↗
• MalfunctionApr 1, 2019Nonstandard Device; Charging Problem

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE MOTION NEGATIVE PRESSURE WOUND THERAPY DEVICE WAS NOT HOLDING A CHARGE WHILE ON A PATIENT; HOWEVER, THERE WAS NO SERIOUS INJURY, THE PATIENT DID NOT EXPERIENCE WOUND DETERIORATION AND THE PATIENT DID NOT REQUIRE CONSULTATION AND/OR TREATMENT BY A MEDICAL PROFESSIONAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8469345 ↗
• MalfunctionJan 17, 2019Nonstandard Device; Overheating of Device; Loss of Power

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE MOTION NEGATIVE PRESSURE WOUND THERAPY DEVICE OVERHEATS AND OCCASIONALLY SHUTS DOWN WHILE ON A PATIENT; THOUGH, THERE WAS NO SERIOUS INJURY, THE PATIENT DID NOT EXPERIENCE WOUND DETERIORATION AND THE PATIENT DID NOT REQUIRE CONSULTATION AND/OR TREATMENT BY A MEDICAL PROFESSIONAL.

  Patient problems: Wound Dehiscence

  MAUDE report 8257167 ↗
• MalfunctionJan 8, 2019Defective Alarm; Battery Problem

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE MOTION NEGATIVE PRESSURE WOUND THERAPY DEVICE WAS BEING CHARGED FOR 4 HOURS AND THEN REMOVED FROM THE CHARGER; AND WHILE THE DEVICE STILL WORKS, IT ALARMS FOR 30-40 MINUTES AND THEN SHOWS THE BLINKING BATTERY SYMBOL WHILE ON A PATIENT; THOUGH, THERE WAS NO SERIOUS INJURY, THE PATIENT DID NOT EXPERIENCE WOUND DETERIORATION AND THE PATIENT DID NOT REQUIRE CONSULTATION AND/OR TREATMENT BY A MEDICAL PROFESSIONAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8225879 ↗
• MalfunctionJan 7, 2019Nonstandard Device; Overheating of Device; Smoking

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE MOTION NEGATIVE PRESSURE WOUND THERAPY DEVICE WAS SMOKING/OVERHEATING DURING CHARGING WHILE ON A PATIENT, THOUGH THERE WAS NO SERIOUS INJURY, THE PATIENT DID NOT EXPERIENCE WOUND DETERIORATION AND THE PATIENT DID NOT REQUIRE CONSULTATION AND/OR TREATMENT BY A MEDICAL PROFESSIONAL. THE PATIENT WAS PUT ON RESCUE DRESSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8223009 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161128, K172145. One submission often covers many models, so check the product and lot details in each record.

• Z-2528-2018 · Feb 7, 2018 · Terminated
  Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. 15 Days Negative Pressure Wound Therapy (Model