ReSolveRecalls & reported problems across all models

We found 16 models of ReSolve by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Aug 12, 2020 and Apr 13, 2026 — classified as 1 death, 25 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (23 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ReSolve recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 11, 2024Open, Classified

   Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

   Z-2570-2024 · Root cause: No Marketing Application · Recall details · FDA record ↗

Most reported ReSolve problems

ReSolve models

16 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ReSolve® 00884450680100

  CATHETER AND TIP, SUCTION
  1 recall0 reports
• ReSolve® 00884450580714

  CATHETER, IRRIGATION
  15 reports
• ReSolve® 00884450009482

  CATHETER, IRRIGATION
  1 death4 reports
• ReSolve® 00884450009857

  CATHETER, IRRIGATION
  3 reports
• ReSolve® 00884450362976

  CATHETER, IRRIGATION
  3 reports
• ReSolve® 00884450580639

  CATHETER, IRRIGATION
  3 reports
• ReSolve® 00884450634905

  CATHETER AND TIP, SUCTION
  2 reports
• ReSolve® 00884450685150

  Stents, drains and dilators for the biliary ducts
  2 reports
• ReSolve® 00884450009864

  CATHETER, IRRIGATION
  1 report
• ReSolve® 00884450018408

  CATHETER, IRRIGATION
  1 report
• ReSolve® 00884450230244

  CATHETER, IRRIGATION
  1 report
• ReSolve® 00884450313237

  CATHETER, BILIARY, DIAGNOSTIC
  1 report
• ReSolve® 00884450362969

  CATHETER, IRRIGATION
  1 report
• ReSolve® 00884450580615

  CATHETER, IRRIGATION
  1 report
• ReSolve® 00884450580721

  CATHETER, IRRIGATION
  1 report
• ReSolve® 00884450683927

  Stents, drains and dilators for the biliary ducts
  1 report

Recent ReSolve adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionMar 16, 2026Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE BILIARY LOCKING DRAINAGE CATHETER BROKE OFF WITHIN THE PATIENT DURING THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607638 ↗
• MalfunctionFeb 20, 2026Difficult or Delayed Separation

  CUSTOMER ALLEGED THE DILATOR COULD NOT BE SEPARATED FROM THE DRAIN DURING DRAIN PLACEMENT AND THE HUB SNAPPED. NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402025 ↗
• MalfunctionAug 28, 2025Material Deformation; Material Deformation

  THE ACCOUNT ALLEGES DURING PREP FOR A PROCEDURE, THE INTRODUCER WAS FOUND BENT. THE PROCEDURE WAS FINISHED USING A NEW DEVICE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913080 ↗
• MalfunctionAug 12, 2025Crack; Fracture; Crack; Fracture

  CUSTOMER REPORTS WHILE EXCHANGING A MULTIPURPOSE DRAIN THAT HAD A CRACK IN THE CATHETER, THE CATHETER FELL APART AT THE RADIOPAQUE MARKER LEAVING PART OF THE CATHETER IN THE PATIENT. THEY WERE ABLE TO EVENTUALLY GET THE REST OF THE CATHETER OUT BUT ON INSPECTION IT APPEARS IT WAS ALSO COMING APART ON THE DISTAL SIDE OF THE MARKER AS WELL. NO ADDITIONAL PATIENT DETAILS WERE PROVIDED AND NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22787641 ↗
• MalfunctionJul 29, 2025Difficult to Remove; Difficult to Remove

  THE ACCOUNT ALLEGES THEY COULD NOT REMOVE THE PLASTIC STIFFENING CANNULA. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647427 ↗
• 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 ↗
• InjuryMay 9, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE OUTSIDE HUB OF THE RESOLVE LOCKING DRAINAGE CATHETER BROKE/DETACHED AFTER PLACEMENT. THE CATHETERS WERE PLACED FOR ASCITES AND NEPHROSTOMY FLUID DRAINAGE. A NEW DRAINAGE CATHETER WAS PLACED FOR THIS PATIENT. THE DEVICE IS NOT EXPECTED TO RETURN FOR ENGINEERING EVALUATION. ALL DEVICES HAVE BEEN DISCARDED AT THE ACCOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994365 ↗
• InjuryMay 9, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE OUTSIDE HUB OF THE RESOLVE LOCKING DRAINAGE CATHETER BROKE/DETACHED AFTER PLACEMENT. THE CATHETERS WERE PLACED FOR ASCITES AND NEPHROSTOMY FLUID DRAINAGE. A NEW DRAINAGE CATHETER WAS PLACED FOR THIS PATIENT. THE DEVICE IS NOT EXPECTED TO RETURN FOR ENGINEERING EVALUATION. ALL DEVICES HAVE BEEN DISCARDED AT THE ACCOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994357 ↗
• InjuryMay 9, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE OUTSIDE HUB OF THE RESOLVE LOCKING DRAINAGE CATHETER BROKE/DETACHED AFTER PLACEMENT. THE CATHETERS WERE PLACED FOR ASCITES AND NEPHROSTOMY FLUID DRAINAGE. A NEW DRAINAGE CATHETER WAS PLACED FOR THIS PATIENT. THE DEVICE IS NOT EXPECTED TO RETURN FOR ENGINEERING EVALUATION. ALL DEVICES HAVE BEEN DISCARDED AT THE ACCOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994356 ↗
• InjuryMay 9, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE OUTSIDE HUB OF THE RESOLVE LOCKING DRAINAGE CATHETER BROKE/DETACHED AFTER PLACEMENT. THE CATHETERS WERE PLACED FOR ASCITES AND NEPHROSTOMY FLUID DRAINAGE. A NEW DRAINAGE CATHETER WAS PLACED FOR THIS PATIENT. THE DEVICE IS NOT EXPECTED TO RETURN FOR ENGINEERING EVALUATION. ALL DEVICES HAVE BEEN DISCARDED AT THE ACCOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994355 ↗
• InjuryMay 9, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE OUTSIDE HUB OF THE RESOLVE LOCKING DRAINAGE CATHETER BROKE/DETACHED AFTER PLACEMENT. THE CATHETERS WERE PLACED FOR ASCITES AND NEPHROSTOMY FLUID DRAINAGE. A NEW DRAINAGE CATHETER WAS PLACED FOR THIS PATIENT. THE DEVICE IS NOT EXPECTED TO RETURN FOR ENGINEERING EVALUATION. ALL DEVICES HAVE BEEN DISCARDED AT THE ACCOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994354 ↗
• InjuryMay 9, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE OUTSIDE HUB OF THE RESOLVE LOCKING DRAINAGE CATHETER BROKE/DETACHED AFTER PLACEMENT. THE CATHETERS WERE PLACED FOR ASCITES AND NEPHROSTOMY FLUID DRAINAGE. A NEW DRAINAGE CATHETER WAS PLACED FOR THIS PATIENT. THE DEVICE IS NOT EXPECTED TO RETURN FOR ENGINEERING EVALUATION. ALL DEVICES HAVE BEEN DISCARDED AT THE ACCOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994353 ↗
• InjuryMay 9, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE OUTSIDE HUB OF THE RESOLVE LOCKING DRAINAGE CATHETER BROKE/DETACHED AFTER PLACEMENT. THE CATHETERS WERE PLACED FOR ASCITES AND NEPHROSTOMY FLUID DRAINAGE. A NEW DRAINAGE CATHETER WAS PLACED FOR THIS PATIENT. THE DEVICE IS NOT EXPECTED TO RETURN FOR ENGINEERING EVALUATION. ALL DEVICES HAVE BEEN DISCARDED AT THE ACCOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994352 ↗

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