SmartPill 50100100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04260167482712), received between Nov 8, 2019 and Oct 13, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Entrapment of Device” (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.

• InjuryOct 13, 2022Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE PATIENT SWALLOWED A CAPSULE WHICH DID NOT PASS THROUGH THEIR SYSTEM. THE DOCTOR TRIED THROUGH THE PATIENT'S COLON, THEN AFTER A CAT SCAN IT WAS REVEALED THAT THE PILL WAS IN THE PATIENT'S STOMACH NOT THEIR COLON. AT THAT POINT, THE DOCTOR REMOVED THE CAPSULE. THE PATIENT HAD SURGERY A FEW YEARS AGO FOR CAMERON'S LESIONS AND THE DOCTOR INDICATED THE SURGERY MAY HAVE EFFECTED HER ABILITY TO PASS THE PILL. THE PATIENT WENT THROUGH MANY WEEKS OF DISTRESS AND HAD AN UNNECESSARY COLONOSCOPY, AND CONTRACTED A URINARY TRACT INFECTION AFTER THE COLONOSCOPY.

  Patient problems: Foreign Body In Patient; Urinary Tract Infection

  MAUDE report 15600004 ↗
• InjurySep 25, 2020Loss of Data; Loss of Data

  ACCORDING TO THE REPORTER, THEY HAD A BLANK STUDY. THE CUSTOMER ADVISED THAT THEY CONFIRMED THE RECEIVER PAIRED WHEN THE PATIENT WAS SENT HOME. THE CUSTOMER WAS INFORMED BY THE PATIENT THAT AFTER THE 3RD DAY, THERE WERE NO PH READINGS. TECHNICAL SUPPORT ADVISED CUSTOMER TO SEND IN STUDY FOR REVIEW. CUSTOMER ALSO STATED THE PATIENT HAD X-RAY AND CONFIRMED CAPSULE HAS PASSED. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 10585505 ↗
• InjuryNov 8, 2019Unintended Application Program Shut Down; Unintended Application Program Shut Down

  ACCORDING TO THE REPORTER, SOMETIME WITHIN THE FIRST SEVERAL HOURS, THE RECORDER POWERED OFF. WHEN THE PATIENT CALLED THE CUSTOMER, THEY ATTEMPTED TO POWER THE RECORDER BACK ON, BUT IT FAILED TO POWER UP. WHEN THEY POWERED THE RECORDER ON, THEY PERFORMED AN UPLOAD OF THE STUDY, AND THEY ONLY RECEIVED A 2 MINUTE DATA. TECHNICAL SUPPORT REVIEWED THE DATA AND IT APPEARED THAT THE CAPSULE HAD ZERO VOLTAGE FROM THE ONSET OF THE STUDY, AND THE RECORDER'S VOLTAGE HAS BEEN JUST ABOVE 8 VOLTS AS IT SHOULD BE. THEY INFORMED THE CUSTOMER THAT THE STUDY FAILED BECAUSE OF THE CAPSULE FAILURE. THE CUSTOMER STATED THAT THERE WAS A CONNECTION THOUGH THERE WAS AN "X" ON THE MONITOR, THEY HAD THE PATIENT ON LIVE MONITORING, AND HAD PICTURES. THE PATIENT WAS ALSO SENT FOR X-RAY TO CONFIRM THE LOCATION OF THE CAPSULE. TECHNICAL SUPPORT RESPONDED THAT IT WAS CERTAIN THE CAPSULE WAS EMITTING A SIGNAL AT TIME THE STUDY INITIALIZED, BUT IT WAS POSSIBLE THE CAPSULE COULD "DIE" AT ANY TIME IF THE BATTERY WAS DEFECTIVE, OR IF IT STOPPED TRANSMITTING, OR IF THERE WA S INTERFERENCE. THE CUSTOMER INDICATED THERE WAS NO IMPLANTED DEVICE, BUT THERE WAS A "LINX DEVICE". THE PATIENT PASSED THE CAPSULE. THERE WAS NO

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9294241 ↗