Impress® 00884450109373Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00884450109373), received between Feb 20, 2020 and May 17, 2023 — classified as 19 injuries.

The most frequently reported specific device problem is “Fracture” (18 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2023Fracture; Material Separation; Fracture; Material Separation

  MERIT MEDICAL SOUTH JORDAN RECEIVED A CATHETER THAT APPEARS TO BE A TIP DETACHMENT. IT IS CURRENTLY UNKNOWN WHEN OR HOW THE TIP DETACHED. BLOOD IS PRESENT ON THE DEVICE SO IT IS LIKELY TO HAVE BEEN DURING A PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16948927 ↗
• InjuryApr 18, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ENDOVASCULAR UTERINE ARTERY EMBOLIZATION PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT'S LEFT COMMON ILIAC ARTERY. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE RIGHT FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S RIGHT COMMON ILIAC ARCH DURING THE CROSSOVER ATTEMPT UNDER FLUOROSCOPY GUIDANCE. DURING CATHETER MANIPULATIONS OVER AN INTERVENTIONAL GUIDEWIRE, THE TIP OF THE CATHETER DETACHED FROM THE PATIENT'S LEFT COMMON ILIAC ARTERY. THE FOREIGN BODY WAS NOT RETRIEVED AT THE TIME OF DETACHMENT. THE PATIENT WAS LATER TRANSFERRED TO THE SURGICAL UNIT FOR SUCCESSFUL FOREIGN BODY REMOVAL/INTERVENTION. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16764938 ↗
• InjuryMar 15, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL UTERINE ARTERY [UAE] EMBOLIZATION PROCEDURE, A 5F CATHETER TIP DETACHED IN THE PATIENT'S ARTERY. THE PHYSICIAN HAD ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S CONTRALATERAL ILIO-FEMORAL CONDUIT WITH A GUIDEWIRE AND A 5F CATHETER. DURING OVER-THE-WIRE CATHETER MANIPULATIONS WITHIN THE PATIENT'S ARTERY UNDER FLUOROSCOPY, THE CATHETER TIP DETACHED. THE PHYSICIAN SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE LIBERATING THE VESSEL. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545342 ↗
• InjuryFeb 9, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT AFTER GAINING ACCESS TO THE CONTRALATERAL UTERINE ARTERY THE CATHETER TIP WAS FOUND TO BE BROKEN INTO SEVERAL PIECES. A SNARE WAS USED TO SUCCESSFULLY REMOVE ONE OF THE PIECES OF THE TIP. THE OTHER PIECE WAS LEFT WITHIN THE PATIENT AND THE CASE WAS ABORTED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16335608 ↗
• InjuryJan 10, 2023Fracture; Material Separation; Fracture; Material Separation

  THE CUSTOMER ALLEGES THAT DURING A UTERINE ARTERY EMBOLIZATION ANGIOGRAM, THE CATHETER TIP DETACHED. THE PHYSICIAN HAD ACQUIRED IPSILATERAL RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S CONTRALATERAL ILIO-FEMORAL CONDUIT WITH A 5F GUIDE CATHETER AND GUIDE WIRE UNDER FLUOROSCOPY GUIDANCE. DURING A SMALL INJECTION OF CONTRAST, IDENTIFYING THE ACTUAL LOCATION OF THE CATHETER TIP WITHIN THE PATIENT'S ANATOMY UNEXPECTEDLY CONFIRMED THAT THE CATHETER TIP DETACHED WITHIN THE PATIENT'S ARTERIAL VASCULAR SYSTEM. THE PHYSICIAN ATTEMPTED TO USE A VASCULAR SNARE DEVICE TO SUCCESSFULLY EXTERNALIZE THE FOREIGN BODY AS IT FRAGMENTED AGAIN INTO THREE ADDITIONAL PIECES THAT FURTHER MIGRATED WITHIN THE PATIENT'S PERIPHERY. THE FOREIGN BODIES HAD MIGRATED TO THE PATIENT'S FEMORAL, POPLITEAL, AND ANTERIOR TIBIAL ARTERIES. MEDICAL INTERVENTION WAS NECESSARY TO REMOVE THE FOREIGN BODIES FROM WITHIN THE PATIENT'S CONTRALATERAL VASCULAR SYSTEM. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16135284 ↗
• InjuryDec 20, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A UTERINE FIBROID EMBOLIZATION PROCEDURE. THE TIP OF THE CATHETER BROKE WHILE WITHDRAWING IT FROM THE PATIENT. A SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE BROKEN PIECES. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16019733 ↗
• InjuryDec 1, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR INTERVENTION, A CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S ILIO-FEMORAL BIFURCATION WITH A GUIDEWIRE AND THE 5F CATHETER. DURING CATHETER MANIPULATIONS, THE CATHETER TIP DETACHED IN THE PATIENT'S COMMON ILIAC ARTERY. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO CAPTURE AND EXTERNALIZED THE FOREIGN BODY. DURING THE PRIMARY CAPTURE ATTEMPT OF THE FOREIGN BODY, IT FRAGMENTED AGAIN INTO TWO ADDITIONAL PIECES. A SECONDARY ATTEMPT TO CAPTURE AND REMOVE THE FOREIGN BODY WAS ATTEMPTED, AND THE FOREIGN BODY AGAIN FRACTURED INTO TWO ADDITIONAL PIECES WITHIN THE PATIENT'S PERIPHERAL VASCULATURE SYSTEM. A THIRD ATTEMPT WAS MADE RESULTING IN THE SAME OUTCOME FOR THE PATIENT. THE PATIENT WAS ADMITTED AND TRANSFERRED TO THE SURGICAL UNIT FOR FOREIGN BODY REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 15894708 ↗
• InjuryJun 22, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A UTERINE ARTERY EMBOLIZATION PROCEDURE USING THE IMPRESS CATHETER, THE DEVICE WAS DAMAGED AND PIECES OF THE CATHETER BROKE WITHIN THE PATIENT. THE CLINICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE BROKEN PIECES USING A SNARE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14782468 ↗
• InjuryMar 24, 2022Fracture; Material Separation; Fracture; Material Separation

  THE PHYSICIAN ALLEGES THAT DURING A UTERINE FIBROID EMBOLIZATION [UFE] PROCEDURE THE CATHETER TIP DETACHED WITHIN A PATIENT. THE PATIENT ORIGINALLY PRESENTED PRE-PROCEDURE WITH SEVERAL COMORBIDITIES AND POOR DIAGNOSIS. VASCULAR ACCESS WAS ACQUIRED VIA THE RIGHT CONTRALATERAL RETROGRADE FEMORAL ARTERY. THE PHYSICIAN HAD NEGOTIATED THE ILIAC BIFURCATION TO REACH THE CONTRALATERAL UTERINE ARTERIES AND DURING CATHETER MANIPULATIONS THE 5F CATHETER DETACHED INTO TWO PIECES. THE PHYSICIAN NOTED THAT THE PATIENT'S ANATOMY WAS UNREMARKABLE. THE PHYSICIAN SUCCESSFULLY EXTERNALIZED THE TWO FOREIGN BODIES WITH A VASCULAR SNARE DEVICE THUS LIBERATING THE VESSEL. THE PHYSICIAN WAS ABLE TO COMPLETE THE UFE PROCEDURE BY ACQUIRING SECONDARY ACCESS FROM THE PATIENT'S CONTRALATERAL FEMORAL ARTERY WITH A MICROPUNCTURE ASSEMBLY, AND A NEW CATHETER. SELECTED EMBOLIC'S WERE INJECTED INTO THE PATIENTS' BLOOD SUPPLY SUCCESSFULLY EMBOLIZING THE TARGETED FIBROIDS. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS TRANSFERRED TO A RECOVER WARD FOR OBSERVATION. THE PATIENT EXPIRED IN THE RECOVERY WARD POST PROCEDURE. THE PHYSICIAN HAS CONFIRMED THAT THERE WAS NO SUSPECTED ASSOCIATION BETWEEN THE PATIENT DEATH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13894331 ↗
• InjuryMar 23, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A FISTULA GRAM PROCEDURE, AFTER SELECTIVELY CATHETERIZING THE PATIENT'S BRACHIAL ARTERY, AN ARTERIOGRAM WAS COMPLETED TO SUCCESSFULLY EVALUATE PATENCY OF THE RADIAL AND ULNAR ARTERY. DURING REMOVAL OF THE CATHETER, THE TIP DETACHED AND LODGED WITHIN THE PATIENT'S DISTAL RADIAL ARTERY. AFTER MULTIPLE ATTEMPTS TO UNSUCCESSFULLY REMOVE THE FOREIGN BODY FROM THE PATIENT, THE PHYSICIAN TRANSFERRED THE PATIENT TO A HOSPITAL FOR SURGICAL REMOVAL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13870160 ↗
• InjuryMar 23, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A TRANSJUGULAR INTRAHEPATIC PORTOYSTEMIC SHUNT (TIPS) PROCEDURE, THE 4FR CATHETER DETACHED WITHIN A BRANCH OF THE PATIENT'S HEPATIC VEIN. THE ATTENDING CLINICIAN WAS ABLE TO SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE THUS LIBERATING THE VEIN. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13870148 ↗
• InjuryMar 17, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A UTERINE FIBROID EMBOLIZATION PROCEDURE, THE TIP OF THE DIAGNOSTIC 5F CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE FEMORAL ARTERIAL ACCESS, AND DURING CATHETER MANIPULATIONS, OVER A GUIDEWIRE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE BUT WAS UNSUCCESSFUL.

  Patient problems: Foreign Body In Patient

  MAUDE report 13802962 ↗
• InjuryFeb 15, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A UAE PROCEDURE, THE CATHETER TIP DETACHED. AN ATTEMPT WAS MADE TO SNARE OUT THE TIP; HOWEVER, IT FURTHER FRACTURED INTO MULTIPLE PIECES WHICH GOT STUCK IN THE ARTERY. THE PHYSICIAN NEEDED THREE HOURS TO REMOVE ALL FRAGMENTS FROM THE ARTERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13536862 ↗
• InjuryJun 22, 2021Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation

  THE ACCOUNT ALLEGES THAT DURING A FIBROID EMBOLIZATION THE PHYSICIAN TORQUED THE CATHETER TO THE POINT IT BECAME SEVERELY TWISTED. IN AN ATTEMPT TO UNTWIST, A STIFF GUIDE WIRE WAS INSERTED TO STRAIGHTEN THE CATHETER. WITHOUT CHECKING TO MAKE SURE THE CATHETER WAS STRAIGHT, THE CATHETER WAS PULLED AGGRESSIVELY AND DETACHED IN THE DISTAL END OF THE PATIENT. THE DETACHED PIECE WAS SUCCESSFULLY COLLECTED WITH A SNARE. NO PATIENT HARM TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046713 ↗
• InjuryApr 13, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A UTERINE ARTERY EMBOLIZATION, THE IMPRESS UAC CATHETER TIP GOT DETACHED. AS THEY ATTEMPTED TO SNARE IT OUT, BUT IT DETACHED FURTHER AND GOT STUCK IN THE ARTERY. THE PROCEDURE WAS STOPPED. NO PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11658931 ↗
• InjuryDec 10, 2020Fracture; Material Separation; Fracture; Material Separation

  THE PHYSICIAN ALLEGES THAT DURING A PROSTATIC ARTERY EMBOLIZATION (PAE) PROCEDURE, TO IMPROVE LOWER URINARY TRACT SYMPTOMS. THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S VASCULATURE UNDER FLUOROSCOPY TO THE TARGETED UTERINE ARTERY OF INTEREST. DURING CATHETER MANIPULATIONS OVER A GUIDEWIRE THE CATHETER TIP DETACHED. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY RETRIEVE THE FOREIGN BODY FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10985374 ↗
• InjuryDec 3, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A UTERINE ARTERY EMBOLIZATION [UAE] PROCEDURE THE 5F CATHETER FRAGMENTED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE ARTERIAL ACCESS. DURING CATHETER MANIPULATIONS OVER A GUIDEWIRE UNDER FLUOROSCOPY, THE CATHETER TIP DETACHED WITHIN THE SUPERIOR MESENTERIC ARTERY (SMA). THE PHYSICIAN NOTED, THE PATIENT'S ANATOMY WAS NOT TORTUOUS, CALCIFIED, OR DISEASED. THE TIP DETACHMENT WAS NOT CONSIDERED LIFE THREATENING. ALL BUT ONE SMALL PIECE OF THE FOREIGN BODY WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT VIA VASCULAR SNARE DEVICE. TO AVOID POSSIBLE MIGRATION OF THE REMAINING FOREIGN BODY, THE PHYSICIAN DEPLOYED A STENT TO PIN THE FOREIGN BODY IN PLACE. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO OTHER INJURIES TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 10938745 ↗
• InjuryDec 3, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN EMERGENT UTERINE ARTERY EMBOLIZATION [UAE] PROCEDURE FOR POST-PARTUM HEMORRHAGING, THE 5F CATHETER FRAGMENTED WITHIN THE (B)(6)-YEAR-OLD FEMALE PATIENT. THE PATIENT EXPIRED 3 HOURS POST UAE PROCEDURE. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS. DURING CATHETER MANIPULATIONS OVER A GUIDEWIRE, UNDER FLUOROSCOPY AT THE PATIENT'S AORTIC BIFURCATION, THE CATHETER TIP DETACHED. THE PHYSICIAN NOTED, THE PATIENT'S ANATOMY WAS NOT TORTUOUS, CALCIFIED, OR DISEASED. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DETACHED FOREIGN BODY WITH A VASCULAR SNARE DEVICE WHEN THE FOREIGN BODY FRAGMENTED AGAIN INCREASING THE INTERVENTIONAL PROCEDURE TIME AND DELAYING THE EMERGENT UAE PROCEDURE. ALL FOREIGN BODY FRAGMENTS WERE SUCCESSFULLY REMOVED FROM THE ABDOMINAL AORTA, RIGHT EXTERNAL ILIAC, AND COMMON FEMORAL ARTERIES. [PICTURES ATTACHED IN AN E-MAIL] POST-PROCEDURE: THE PATIENT WAS ADMITTED TO A RECOVERY UNIT. THE ACCOUNT ALLEGES THAT THE CAUSE OF DEATH WAS UNRELATED TO THE CATHETER DETACHMENT HOWEVER, THE EMERGENT UAE WAS DELAYED DUE TO THE FOREIGN BODY RETRIEVAL INTERVENTIONS. THE PATIENT HAD EXPIRED THREE HOURS LATER POST-PROCEDURE ON (B)

  Patient problems: Foreign Body In Patient

  MAUDE report 10938665 ↗
• InjuryFeb 20, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGED THAT DURING A UTERINE ARTERY EMBOLIZATION (UAE) PROCEDURE, THE CATHETER FRACTURED WITHIN THE PATIENT'S LEFT INTERNAL ILIAC ARTERY. THE EMBOLIZATION PROCEDURE WAS ABORTED AND CATHETER TIP RECOVERY WAS ATTEMPTED WITH A VASCULAR SNARE DEVICE VIA FEMORAL ARTERY ACCESS. THE CATHETER TIP FRAGMENTED AGAIN DURING THIS PROCESS AND THE ENDOVASCULAR REMOVAL WAS UNSUCCESSFUL. THE PATIENT WAS REFERRED FOR SURGICAL REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 9735316 ↗