Model 2404 Maestro Patient KitRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00857334004347), received between Oct 30, 2018 and Jul 18, 2019 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Low impedance” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2019Low impedance; Low impedance

  PATIENT OBSERVED A RED LIGHT ON THE MOBILE CHARGER AND WAS UNABLE TO CHARGE DEVICE. THE PATIENT REACHED OUT TO THE CLINICAL SITE TO SCHEDULE A VISIT. UPON COMMUNICATION WITH DEVICE USING THE CLINICAL PROGRAMMER, ERROR CODE 4 WAS OBSERVED, "TOO MANY THERAPY RETRIES". PATIENT WILL BE GOING TO THE OFFICE FOR A VISIT ON (B)(6) 2019 TO HAVE THE LOG FILES DOWNLOADED ONTO A USB DRIVE. ERRORS ARE DUE TO LOW IMPEDANCE ON THE DEVICE LEADS.

  Patient problems: Failure of Implant

  MAUDE report 8802628 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINING OF STERNAL PAIN, NAUSEA, VOMITING, AND GENERAL PAIN AT RNR IMPLANT SITE. PATIENT HAS NOT BEEN BY THE IMPLANTING PHYSICIAN DUE TO THE SIGNIFICANT TRAVEL DISTANCE REQUIRED. PATIENT IS REQUESTING REMOVAL OF DEVICE AND INFORMATION ON POTENTIAL ALTERNATIVE HOSPITALS FOR TREATMENT.

  Patient problems: Nausea; Pain; Vomiting

  MAUDE report 8758102 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT (B)(6) HAD AN EXPLANT ON (B)(6) 2019 WITHOUT COMPLICATIONS AND WAS DISCHARGED THAT DAY. THE PATIENT CAME BACK INTO THE HOSPITAL ON (B)(6) 2019 AT 23:51 FOR LEFT ABDOMINAL WALL HEMATOMA AT THE SITE OF THE PREVIOUS NEUROMODULATOR DEVICE. THE PATIENT UNDERWENT SURGERY EARLY THIS MORNING, (B)(6) 2019 FOR EVACUATION OF THE HEMATOMA. THE PROCEDURE WENT WELL AND THE PATIENT WAS DISCHARGED THE SAME DAY.

  Patient problems: Hematoma

  MAUDE report 8700542 ↗
• InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DEVICE WAS REMOVED ON (B)(6) 2019 AFTER THE PATIENT EXPERIENCED SYMPTOMS OF INDIGESTION AND HEARTBURN.

  Patient problems: Heartburn/Indigestion

  MAUDE report 8604095 ↗
• InjuryOct 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A VBLOC DEVICE PLACED YEARS AGO IN (B)(6) AND HAS NOT CHARGED OR USED THE DEVICE IN YEARS. HOWEVER, THE PATIENT HAS COMPLAINED ABOUT A "LUMP GROWING IN THE SAME PLACE AS WHERE THE VBLOC DEVICE IS IMPLANTED." THE PATIENT CLAIMS THERE IS POTENTIAL BLEEDING AS THERE IS A GROWING BRUISE AND THE BLACK AND BLUE AREA IS CONTINUING TO SPREAD. THE PATIENT REPORTED THE AFFECTED AREA IS ABOUT 6-7 INCHES AND IS EXPERIENCING SHARP PAINS. IT IS UNKNOWN IF THE PATIENT HAS HAD THE VBLOC EXPLANTED, THE PATIENT NOW LIVES IN (B)(6), RESHAPE LIFESCIENCES RECOMMENDED TO THE PATIENT TO SEE A PHYSICIAN IN THE AREA.

  Patient problems: Bruise/Contusion

  MAUDE report 8018997 ↗