ReSolve® 00884450580639Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450580639), received between Jul 2, 2025 and Apr 13, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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.

• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DRAINAGE CATHETER WAS USED TO TREAT A FEMALE PATIENT WITH CANCER. THE PRIMARY USE OF THE DEVICE WAS FOR PERCUTANEOUS DRAINAGE OF FLUID OTHER THAN BILE, WITH INDICATION OF PLEURAL EFFUSION. THE LOCATION OF THE DRAIN WAS THE PLEURAL SPACE, AND WAS IN USE FOR 18 DAYS. DURING THIS TIME THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE DEVICE WAS REMOVED ON (B)(6) 2026. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Pneumothorax

  MAUDE report 24861236 ↗
• MalfunctionJul 2, 2025Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT WHEN LOCKING THE CATHETER, THE SIDE WHITE WALL CAME OFF ON THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384445 ↗
• MalfunctionJul 2, 2025Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT WHEN LOCKING THE CATHETER, THE SIDE WHITE WALL CAME OFF ON THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384438 ↗