Impress® 00884450654507Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00884450654507), received between Nov 22, 2022 and Sep 25, 2024 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2024Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING THE AVF PROCEDURE, THE NURSE FOUND THAT THE CATHETER TIP WAS DETACHED WHEN OPENING THE PACKAGE. IN ORDER TO CONTINUE THE PROCEDURE, A NEW PRODUCT WAS OPENED AND THE PROCEDURE WAS CARRIED OUT, BUT THE CATHETER TIP DETACHED AGAIN INSIDE THE PATIENT'S BODY. THE PHYSICIAN WAS ABLE TO RETRIEVE IT IMMEDIATELY WITH NO HARM OR INJURY TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20300487 ↗
• InjurySep 3, 2024Break; Break

  THE ACCOUNT ALLEGES THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR PTA (THROMBECTOMY) SURGERY, WHICH WAS EXPECTED TO TAKE 1 HOUR. WHEN THE MERIT IMPRESS ANGIOGRAPHIC CATHETER WAS USED DURING THE SURGERY, THE TIP OF THE CATHETER BROKE IN THE PATIENT'S BLOOD VESSEL, CAUSING THE ORIGINAL 1 HOUR THE ACHIEVABLE SURGERY WAS EXTENDED BY 1.5 HOURS DUE TO THE REMOVAL OF THE BROKEN TIP AND THE ADDITION OF VASCULAR EXPLORATION. MEDICAL STAFF PROVIDED WOUND DRESSING TO STOP BLEEDING, DRUG TREATMENT, BLOOD AND URINE TESTS, ETC. AFTER THE OPERATION, AND CONTINUED OBSERVATION. THE PATIENT'S CONDITION WAS STABLE AND NO COMPLICATIONS OCCURRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20127000 ↗
• InjuryJun 11, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE DIALYSIS ACCESS BALLOON DILATATION PROCEDURE, IT WAS FOUND THAT THE TIP OF CATHETER WAS CRACKED AND BROKEN DURING THE ANGIOGRAPHY PROCESS. THE TIP OF CATHETER STILL STAYED ON THE END OF AN ARTERIOVENOUS ANASTOMOSIS AND HAS NOT BEEN REMOVED FROM PATIENT'S BODY. THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 19510734 ↗
• InjuryMay 7, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING USE OF THE CATHETER, THE TIP OF THE CATHETER DETACHED. THE TIP WAS REMOVED WITH VASCULAR SNARE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264374 ↗
• InjuryMar 25, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, THE BLACK TIP OF THE CATHETER DETACHED AND REMAINED WITHIN THE BLOOD VESSEL. THE DETACHED PORTION WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT'S BLOOD VESSEL. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18976275 ↗
• InjuryMar 12, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ANGIOGRAPHY THE CATHETER TIP DETACHED. THE PRODUCT WAS ATTEMPTED TO BE USED FOR INTERNAL ILIAC ARTERY IN RELATION TO A TYPE II ENDOLEAK. THE CATHETER WAS INSERTED FROM RIGHT FEMORAL ARTERY AND DELIVERED THROUGH AORTIC BIFURCATION TO LEFT SIDE. WHEN ANGIOGRAPHY WAS PERFORMED WITH THE UNIT AT THE VICINITY OF LEFT INTERNAL ILIAC ARTERY, IT WAS SUSPECTED THAT THE TIP OF THE CATHETER HAD GOT CRACKED. THUS, THE UNIT WAS PULLED BACK INTO A SHEATH. HOWEVER, THE TIP GOT COMPLETELY SHEARED OFF AT THAT TIME. AS THE TIP WAS FLOATING WITHIN LEFT SUPERFICIAL FEMORAL ARTERY (SFA), THE RETRIEVAL OF THE TIP WAS ATTEMPTED WITH A SNARE. HOWEVER, THE TIP WENT DEEP INTO THE PERIPHERAL REGION OF THE SFA. THUS, THE VESSEL WAS CUT DOWN UNDER GENERAL ANESTHESIA, AND THE TIP WAS SUCCESSFULLY RETRIEVED WITH A FOGARTY CATHETER. THE PHYSICIAN STATED THAT THE ANATOMY HAD NO STENOSIS OR SIGNIFICANT TORTUOSITY, AND THAT THE CRACKING AND THE DETACHMENT OCCURRED DESPITE THE USUAL MANIPULATION OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18890884 ↗
• InjuryFeb 5, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN EMBOLIZATION PROCEDURE FOR INTERNAL ILIAC ARTERY THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT. THE CATHETER WAS INSERTED FROM FEMORAL ARTERY AND DELIVERED TO THE INTERNAL ILIAC ARTERY. DURING THE PROCEDURE, A GUIDEWIRE PENETRATED THE SIDE OF THE TIP OF THE CATHETER, CAUSING THE TIP DETACHMENT. IT WAS FOUND THAT THE WIRE WENT OUT FROM THE CATHETER BEFORE REACHING ITS TIP HOLE. THE PHYSICIAN MOVED THE WIRE BACKWARD AND FORWARD WITHIN THE CATHETER SEVERAL TIMES, AND IT WAS FOUND THAT THE WIRE DEVIATED FROM THE CATHETER EVERY TIME. THUS, THE CATHETER WAS ATTEMPTED TO BE PULLED BACKWARD. AT THAT TIME, THE DETACHMENT WAS CONFIRMED. THE MAJOR PORTION OF THE CATHETER WAS WITHDRAWN OUT, AND IT WAS FOUND TO BE BROKEN OFF AT THE JUNCTION BETWEEN THE BLACK TIP AND THE PURPLE SHAFT. THE VESSEL HAD SLIGHT CALCIFICATION AS WELL AS TORTUOSITY. THE DETACHED PORTION HAS BEEN REMAINING WITHIN ILIOLUMBAR ARTERY, AND IT HAS NOT BEEN RETRIEVED DUE TO A PHYSICIAN'S DECISION.

  Patient problems: Foreign Body In Patient

  MAUDE report 18646318 ↗
• InjuryDec 12, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT AND WAS SUCCESSFULLY RETRIEVED. A GOOD FAITH EFFORT TO COLLECT ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN SUCCESSFULLY COMPLETED IN A TIMELY MANNER. NO ADDITIONAL INFORMATION ABOUT THIS EVENT HAS BEEN PROVIDED BY THIS ACCOUNT TO THE MANUFACTURER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFO IS RECEIVED. THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18313054 ↗
• MalfunctionNov 22, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING PROCEDURE THE TIP BROKE OFF INSIDE THE SHEATH. THE PHYSICIAN WAS ABLE TO REMOVE THE SHEATH WITH THE BROKEN TIP STILL INSIDE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15844413 ↗