ReSolve Mini™ 00884450720158Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450720158), received between Aug 13, 2025 and Nov 3, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Complete Blockage; Obstruction of Flow; Infusion or Flow Problem; Complete Blockage; Obstruction of Flow; Infusion or Flow Problem

  THE ACCOUNT ALLEGES THAT THE DRAINAGE CATHETER BECAME OCCLUDED. DURING SUBSEQUENT REMOVAL, THE TIP INJURED THE PORTAL VEIN, CAUSING BLEEDING. SURGERY WAS PERFORMED. ACCORDING TO THE CUSTOMER, WHEN REMOVING THE CATHETER, THE OPERATOR DID NOT PERFORM THE PROCEDURE TO RELEASE THE FIXATION OF THE SUTURE ATTACHED TO THE CATHETER TIP. HOWEVER, UNDER FLUOROSCOPY, IT WAS CONFIRMED THAT THE TIP SHAPE HAD STRAIGHTENED. NO GUIDEWIRE OR SIMILAR DEVICE WAS INSERTED INTO THE CATHETER LUMEN. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 23458527 ↗
• InjuryAug 13, 2025Break; Break

  THE ACCOUNT ALLEGES THAT A PATIENT BEING MONITORED IN PULMONOLOGY UNDERWENT REMOVAL OF A RESOLVE PIGTAIL 8.5FR PLEURAL DRAIN. THIS SYSTEM REQUIRES A SPECIFIC UNLOCKING DEVICE, NOT AVAILABLE IN SERVICE AND LIKELY INCLUDED IN THE ORIGINAL BOX USED DURING RADIOLOGY PLACEMENT. IN ACCORDANCE WITH THE ALTERNATIVES MENTIONED IN THE PRODUCT'S USER MANUAL, A SECTION OF THE DRAIN UPSTREAM OF THE LOCKING SYSTEM WAS CREATED AFTER CLAMPING WITH FORCEPS. THE DRAIN WAS REMOVED WITHOUT DIFFICULTY. HOWEVER, THE INTERNAL HOLDING WIRE (THE LOCKING SYSTEM WIRE) REMAINED IN THE PATIENT'S CHEST. AN ATTEMPT TO MANUALLY REMOVE THIS WIRE WAS INITIATED BUT HAD TO BE INTERRUPTED DUE TO PAIN EXPERIENCED BY THE PATIENT. REMOVAL WAS THEREFORE POSTPONED, A DRESSING WAS APPLIED, AND A REASSESSMENT WAS SCHEDULED FOR THE FOLLOWING DAY. AT THIS REASSESSMENT, THE THREAD WAS NO LONGER PRESENT UNDER THE DRESSING, SUGGESTING UNDOCUMENTED SPONTANEOUS OR ACCIDENTAL REMOVAL. THE PATIENT WAS INFORMED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22796974 ↗