Invia Motion 15 Days 200.8589Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07612367053167), received between Jan 7, 2019 and Apr 29, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2019Nonstandard Device; Aborted Charge; Temperature Problem

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY DEVICE WAS GETTING HOT AND WAS NOT FULLY 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8560058 ↗
• MalfunctionJan 7, 2019Failure to Charge; Temperature Problem

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE MOTION NEGATIVE PRESSURE WOUND THERAPY DEVICE WAS NOT HOLDING A CHARGE AND FELT WARM 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 Consequences Or Impact To Patient

  MAUDE report 8222759 ↗

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