AffloVest 8100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816305024005), received between May 25, 2024 and May 25, 2024 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JANUARY 4, 2024, THE PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT BY HIS PARENTS BECAUSE HE HAD BEEN SICK. UPON EXAMINATION, INCLUDING X-RAYS, IT WAS DISCOVERED THE PATIENT HAD MULTIPLE RIB FRACTURES THOUGH NO CAUSE WAS IDENTIFIED. DURING A FOLLOW APPOINTMENT WITH HIS PRIMARY CARE PHYSICIAN (PCP) ON JANUARY 23, 2024, THE PCP ASSESSMENT NOTED THE PATIENT'S SIGNIFICANT HISTORY OF CEREBRAL PALSY AND LIMITED MOBILITY INDICATING THAT COULD LEAD TO BRITTLE BONES AND THAT REGULAR USE OF A PERCUSSIVE DEVICE MAY HAVE CONTRIBUTED TO THE FRACTURED RIBS. INVESTIGATION OF THE RIB FRACTURES WITH DEXA SCAN AND DISCONTINUATION OF USE OF THE PERCUSSIVE DEVICE WERE ALSO DISCUSSED AT THIS APPOINTMENT. USE OF THE DEVICE WAS DISCONTINUED AND PRODUCT WAS RETURNED TO THE DISTRIBUTOR THAT PROVIDED THE PRODUCT TO THE PATIENT. ON APRIL 16, 2024, DURING THE PROCESS OF RETURNING THE PRODUCT THE PARENT INFORMED THE DISTRIBUTOR OF THE EVENT. THE DISTRIBUTOR NOTIFIED MANUFACTURER, TACTILE MEDICAL, ON APRIL 26, 2024. USE OF THE DEVICE WAS DISCONTINUED AND PRODUCT WAS RETURNED. TACTILE MEDICAL HAS RECEIVED NO INDICATION OF ANY FURTHER MEDICAL EVALUATIONS RELATING TO THE REPORTED EVENT.

  Patient problems: Multiple Fractures

  MAUDE report 19398331 ↗