DeRoyal M7035-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00749756113427), received between Dec 16, 2025 and Dec 19, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 reports).

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 16, 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.

• MalfunctionDec 19, 2025Device Dislodged or Dislocated

  ON [REDACTED], THE PEDIATRIC PATIENT HAD THE ELBOW POSITIONER/IMMOBILIZER IN PLACE ON THE PATIENT'S LEFT ARM IN ORDER TO PROVIDE PROTECTION FOR THE INTRAVENOUS PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] LINE AND DRESSING. WHILE REPOSITIONING THE PATIENT, THE NURSE NOTED THAT THE METAL ROD HAD DISLODGED FROM THE CLOTH COVERING AND WAS DIGGING INTO THE PATIENT'S UNDERARM CAUSING A PUNCTURE WOUND. (THERE WAS ALSO AN EARLIER REPORT OF THE SAME PRODUCT ALSO DISLODGING FROM THE CLOTH COVERING BUT NO INJURY WAS NOTED WITH THAT FIRST ONE - THAT PRODUCT WAS ALSO DISCARDED). THE PATIENT'S LEFT AXILLA INJURY SITE ASSESSED BY THE PEDIATRIC SURGERY NURSE PRACTITIONER, CLEANSED WITH NORMAL SALINE AND PACKED WITH A WICK DRESSING AND MEPILEX APPLIED. DAILY WOUND CARE PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23849852 ↗
• MalfunctionDec 16, 2025Material Puncture/Hole; Material Puncture/Hole

  A USER FACILITY REPORTED, "THIS PATIENT HAD WELCOME SLEEVES ON FOR IV PROTECTION. DURING A REPOSITION, THIS RN NOTED THAT THE METAL BAR HAD PUNCTURED THROUGH THE WELCOME SLEEVE. WELCOME SLEEVE WAS THROWN AWAY, SKIN CHECK COMPLETED WITH NO SIGNS OF INJURY AT THIS TIME AND A NEW WELCOME SLEEVE WAS PLACED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815361 ↗
• MalfunctionDec 16, 2025Material Puncture/Hole; Material Puncture/Hole

  A USER FACILITY REPORTED, "PATIENT HAD ELBOW IMMOBILIZER ON L ARM TO PROTECT PICC LINE/DRESSING. PATIENT IS VERY CONTRACTED AND MOVES FREQUENTLY. ON REMOVAL OF ELBOW IMMOBILIZER, IT WAS NOTED THAT METAL ROD HAD DISLODGED FROM CLOTH COVERING AND WAS DIGGING INTO PATIENT'S UNDERARM CAUSING PUNCTURE WOUND."

  Patient problems: Laceration(s)

  MAUDE report 23815360 ↗