ReSolve® 00884450009482Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450009482), received between Sep 30, 2020 and Dec 14, 2021 — classified as 1 death, 3 injuries.

The most frequently reported specific device problem is “Crack” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathDec 14, 2021Fracture; Material Separation; Fracture; Material Separation

  THE PATIENT WAS ADMITTED AND COMMENCED ON INTRAVENOUS ANTIBIOTICS FOR SUSPECTED CELLULITIS TO BILATERAL LEGS WITH REFERRAL FOR INSERTION OF ASCITIC DRAIN (ABDOMINAL CAVITY) TO REDUCE FLUID RETENTION. DURING THE DRAINAGE TUBE PLACEMENT PROCEDURE, AN 8-FRENCH GAUGE PIGTAIL CATHETER WAS SUCCESSFULLY INSERTED AND SECURED TO THE ANTERIOR ABDOMINAL WALL ON THE RIGHT SIDE IN THE LOWER ILIAC FOSSA. THE CATHETER WAS PLACED UNDER ULTRASOUND GUIDANCE IN THE MEDICAL IMAGING (MI) DEPARTMENT PRIOR TO RETURNING TO THE WARD FOR MONITORING FOR A PLANNED DRAINAGE TIME OF SIX HOURS PRIOR TO REMOVAL (SCHEDULED FOR 20:30 HOURS). THE PATIENT WAS RETURNED TO THE WARD FOR OBSERVATION WITHOUT NOTED COMPLICATIONS FOLLOWING THE PROCEDURE. DURING THE DRAINAGE TUBE REMOVAL PROCEDURE, THE MEDICAL STAFF REPORTED THAT THEY WERE FAMILIAR WITH THIS TYPE OF DRAINAGE CATHETER AND HOW TO REMOVE THE DEVICE FROM THE PATIENT. WHEN THE HUB WAS CUT OFF, A LARGE AMOUNT OF FLUID GUSHED OUT WHICH STARTLED THE NURSE, RESULTING IN LOSS OF GRIP ON THE DRAINAGE CATHETER. THE PATIENT INHALED AT THE SAME TIME, AND THE DRAINAGE CATHETER WITHDREW INTO THE PATIENT'S ABDOMEN RESULTING IN THE UNINTENDED RETENTION. THE HUB WAS NOT KEPT F

  Patient problems: Foreign Body In Patient

  MAUDE report 13005428 ↗
• InjuryOct 5, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THEY TRIED TO EXCHANGE THE 8 FRENCH NEPHROSTOMY TUBE, HOWEVER THE TIP OF THE CATHETER BECAME STUCK ON THE KIDNEY CAPSULE AND A SMALL PIECE WAS RETAINED WITHIN THE TRACT NEAR THE KIDNEY. DESPITE MULTIPLE ATTEMPTS, THE RETAINED PRODUCT COULD NOT BE RETRIEVED FLUOROSCOPICALLY. THE PATIENT IS SCHEDULED TO HAVE UROLOGY REMOVE IT SURGICALLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12576875 ↗
• InjurySep 30, 2020Crack; Crack

  THE ACCOUNT ALLEGES THAT POST-DRAINAGE CATHETER PLACEMENT WITHIN THE PATIENT'S BILIARY SYSTEM, THE DRAINAGE CATHETER BECAME DAMAGED AT THE BEND 15 DAYS LATER AND WOULD NOT CONTINUE TO DRAIN. THE DRAINAGE CATHETER WAS REPLACED FOR THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10609999 ↗
• InjurySep 30, 2020Crack; Crack

  THE ACCOUNT ALLEGES THAT POST-DRAINAGE CATHETER PLACEMENT WITHIN THE PATIENT'S BILIARY SYSTEM, THE DRAINAGE CATHETER BECAME DAMAGED AT THE BEND 7 DAYS LATER AND WOULD NOT CONTINUE TO DRAIN. THE DRAINAGE CATHETER WAS REPLACED FOR THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10609993 ↗