ImpressRecalls & reported problems across all models
Merit Medical Systems, Inc. · 145 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 481
- Deaths reported
- 2
- Injuries reported
- 366
- Recalls
- 0
We found 145 models of Impress by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 481 adverse event reports in the FDA's MAUDE database, received between Apr 10, 2017 and Sep 16, 2026 — classified as 2 deaths, 366 injuries, 113 malfunctions.
The most frequently reported specific device problem is “Fracture” (448 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. 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
Reports received per month, all models
Most reported Impress problems
Device problems
- Fracture448
- Material Separation398
- Break25
- Material Fragmentation11
- Detachment of Device or Device Component10
- Material Integrity Problem7
- Difficult to Remove3
- Material Rupture3
Patient problems
- No Clinical Signs, Symptoms or Conditions309
- Foreign Body In Patient135
- No Known Impact Or Consequence To Patient18
- No Consequences Or Impact To Patient8
- Device Embedded In Tissue or Plaque3
- Insufficient Information3
- Foreign Body Embolism2
- Ischemia2
Impress models
145 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Impress® 00884450032565CATHETER, INTRAVASCULAR, DIAGNOSTIC19 reports
- Impress® 00884450109373CATHETER, INTRAVASCULAR, DIAGNOSTIC19 reports
- Impress® 00884450009222CATHETER, INTRAVASCULAR, DIAGNOSTIC18 reports
- Impress® 00884450038109CATHETER, INTRAVASCULAR, DIAGNOSTIC15 reports
- Impress® 00884450022436CATHETER, INTRAVASCULAR, DIAGNOSTIC14 reports
- Impress® 00884450038185CATHETER, INTRAVASCULAR, DIAGNOSTIC14 reports
- Impress® 00884450032541CATHETER, INTRAVASCULAR, DIAGNOSTIC11 reports
- Impress® 00884450035832CATHETER, INTRAVASCULAR, DIAGNOSTIC11 reports
- Impress® 00884450035948CATHETER, INTRAVASCULAR, DIAGNOSTIC11 reports
- Impress® 00884450646533Catheter, intravascular, diagnostic11 reports
- Impress® 00884450020449CATHETER, INTRAVASCULAR, DIAGNOSTIC10 reports
- Impress® 00884450032558CATHETER, INTRAVASCULAR, DIAGNOSTIC10 reports
- Impress® 00884450020135CATHETER, INTRAVASCULAR, DIAGNOSTIC9 reports
- Impress® 00884450026571CATHETER, INTRAVASCULAR, DIAGNOSTIC9 reports
- Impress® 00884450654507Catheter, intravascular, diagnostic9 reports
- Impress® 00884450030134CATHETER, INTRAVASCULAR, DIAGNOSTIC8 reports
- Impress® 00884450009451CATHETER, INTRAVASCULAR, DIAGNOSTIC7 reports
- Impress® 00884450020012CATHETER, INTRAVASCULAR, DIAGNOSTIC7 reports
- Impress® 00884450020043CATHETER, INTRAVASCULAR, DIAGNOSTIC7 reports
- Impress® 00884450120989CATHETER, INTRAVASCULAR, DIAGNOSTIC7 reports
- Impress® 00884450009215CATHETER, INTRAVASCULAR, DIAGNOSTIC6 reports
- Impress® 00884450009253CATHETER, INTRAVASCULAR, DIAGNOSTIC6 reports
- Impress® 00884450009307CATHETER, INTRAVASCULAR, DIAGNOSTIC6 reports
- Impress® 00884450009420CATHETER, INTRAVASCULAR, DIAGNOSTIC6 reports
- Impress® 00884450009437CATHETER, INTRAVASCULAR, DIAGNOSTIC6 reports
- Impress® 00884450038161CATHETER, INTRAVASCULAR, DIAGNOSTIC6 reports
- Impress® 00884450668122Catheter, intravascular, diagnostic6 reports
- Impress® 00884450712184Catheter, intravascular, diagnostic6 reports
- Impress® 00884450023198CATHETER, INTRAVASCULAR, DIAGNOSTIC5 reports
- Impress® 00884450032534CATHETER, INTRAVASCULAR, DIAGNOSTIC5 reports
- Impress® 00884450038048CATHETER, INTRAVASCULAR, DIAGNOSTIC5 reports
- Impress® 00884450038093CATHETER, INTRAVASCULAR, DIAGNOSTIC5 reports
- Impress® 00884450654538Catheter, intravascular, diagnostic5 reports
- Impress® 00884450009284CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- Impress® 00884450011485CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- Impress® 00884450020098CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- Impress® 00884450023877CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- Impress® 00884450024928CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- Impress® 00884450029541CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- Impress® 00884450668771Catheter, intravascular, diagnostic4 reports
- Impress® 00884450009116CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- Impress® 00884450009376CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- Impress® 00884450009390CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- Impress® 00884450012413CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- Impress® 00884450018897CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- Impress® 00884450020074CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- Impress® 00884450023204CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- Impress® 00884450029558CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- Impress® 00884450035887CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- Impress® 00884450035955CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- Impress® 00884450038192CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- Impress® 00884450660942Catheter, intravascular, diagnostic3 reports
- Impress® 00884450661529Catheter, intravascular, diagnostic3 reports
- Impress® CCatheter, intravascular, diagnostic3 reports
- Impress® 00884450009277CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Impress® 00884450023181CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Impress® 00884450023280CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Impress® 00884450028957CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Impress® 00884450035849CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Impress® 00884450035894CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Impress® 00884450035900CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Impress® 00884450042366CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Impress® 00884450042564CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Impress® 00884450043363CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Impress® 00884450043509CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Impress® 00884450043769CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Impress® 00884450646595Catheter, intravascular, diagnostic2 reports
- Impress® 00884450661567Catheter, intravascular, diagnostic2 reports
- Impress® 00884450668931Catheter, intravascular, diagnostic2 reports
- Impress® 00884450683750Catheter, intravascular, diagnostic2 reports
- Impress® 00884450687567Catheter, intravascular, diagnostic2 reports
- Impress® 00884450687598Catheter, intravascular, diagnostic2 reports
- Impress® 00884450688236Catheter, intravascular, diagnostic1 death2 reports
- Impress® 00884450697375Catheter, intravascular, diagnostic2 reports
- Impress® BCatheter, intravascular, diagnostic2 reports
- Impress® 00884450009109CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450009185CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450009260CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450009291CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450009321CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450009338CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450009352CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450009413CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450009444CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450015551CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450015568CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450020159CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450024973CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450025161CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450026434CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450026519CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450026557CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450027080CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450030493CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450036013CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450036129CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450038024CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450038031CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450038062CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impress® 00884450042373CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
Recent Impress adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794737 ↗DeathApr 2, 2026Fracture; Material Fragmentation; Material Separation
IT WAS REPORTED THAT TIP OF THE CATHETER FRACTURED UPON INSERTION OF THE DEVICE. A SNARE WAS USED TO RETRIEVE THE FRAGMENTED TIP; HOWEVER, IT FRACTURED AGAIN. THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE OPERATING ROOM. A VASCULAR SURGEON PERFORMED A CUT DOWN AND REMOVED THE FRAGMENTS WITH FORCEPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766675 ↗MalfunctionMar 26, 2026Fracture
ACCOUNT REPORTED THAT DURING A PROCEDURE, THE CATHETER BROKE OFF WITH CONCERNS OF MIGRATION TO THE RIGHT VENTRICLE. THIS WAS IMMEDIATELY IDENTIFIED AND PATIENT WAS TRANSFERRED TO THE CATH LAB FOR RETRIEVAL. THE FOREIGN BODY WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT WITHOUT COMPLICATION. THE PATIENT REMAINED IN HOSPITAL FOR OVERNIGHT OBSERVATION AND DISCHARGED THE FOLLOWING DAY.
Patient problems: Foreign Body In Patient
MAUDE report 24698750 ↗MalfunctionMar 11, 2026Material Separation
DURING A PERIPHERAL INTERVENTION WITH AN IMPRESS CATHETER, THE TIP BROKE OFF IN THE THORACIC AORTA. AS A RESULT, THE PATIENT WAS TAKEN FOR AN ADDITIONAL PROCEDURE TO SNARE THE BROKEN TIP WITH A RETRIEVAL BASKET.
Patient problems: Foreign Body In Patient
MAUDE report 24567691 ↗MalfunctionMar 11, 2026Material Separation
DURING A PERIPHERAL INTERVENTION WITH AN IMPRESS CATHETER, THE TIP BROKE OFF IN THE THORACIC AORTA. AS A RESULT, THE PATIENT WAS TAKEN FOR AN ADDITIONAL PROCEDURE TO SNARE THE BROKEN TIP WITH A RETRIEVAL BASKET.
Patient problems: Foreign Body In Patient
MAUDE report 24567690 ↗MalfunctionFeb 11, 2026Fracture
ACCOUNT REPORT THAT DURING TREATMENT OF AN ENDOLEAK IN A STENT-GRAFT, THE BLACK TIP OF THE IMPRESS CATHETER DETACHED. THE OPERATOR HANDLED THE IMPRESS CAREFULLY IN THIS CASE AND DID NOT PERFORM ANY EXCESSIVE MANIPULATION. HE ALSO REPORTED THAT THE IMPRESS DID NOT GET CAUGHT ON THE STENT GRAFT OR OTHERWISE EXERT EXCESSIVE PRESSURE. THE TIP WAS RETRIEVED WITH A CUT-DOWN AND A 14FR COOK CHECK-FLO. IT WAS FOUND THAT THE COMPLAINT PRODUCT HAD PASSED ITS EXPIRATION DATE.
Patient problems: Foreign Body In Patient
MAUDE report 24312515 ↗MalfunctionJan 29, 2026Fracture; Material Fragmentation; Material Separation
THE TIP OF THE IMPRESS DIAGNOSTIC CATHETER DETACHED DURING USE.
Patient problems: Insufficient Information
MAUDE report 24209734 ↗MalfunctionJan 20, 2026Break; Fracture; Material Fragmentation; Material Separation
THE ACCOUNT ALLEGES THAT PRIOR TO USE, THE TIP OF THE DIAGNOSTIC CATHETER WAS FOUND TO BE DETACHED WITHIN THE PACKAGING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24119188 ↗DeathJan 9, 2026Fracture; Material Fragmentation; Material Separation
THE ACCOUNT ALLEGES THAT A 71-YEAR-OLD MALE WITH SIGNIFICANT COMORBIDITIES UNDERWENT EMERGENCY AORTOGRAPHY ON (B)(6) 2025, FOR SUSPECTED MESENTERIC ARTERIAL ISCHEMIA. THE PATIENT WAS CRITICALLY ILL PRIOR TO THE PROCEDURE, WITH HEMODYNAMIC INSTABILITY, INTUBATION, AND VASOACTIVE SUPPORT. DURING REMOVAL OF THE GUIDEWIRE AND EXIT OF THE PIGTAIL CATHETER FROM THE INTRODUCER, FRAGMENTATION OF THE CATHETER TIP WAS IDENTIFIED UNDER FLUOROSCOPY. NO IRREGULARITIES WERE OBSERVED PRIOR TO USE. THE BLACK PIGTAIL SEGMENT FRAGMENTED DURING RETRIEVAL, RESULTING IN FIVE FRAGMENTS; ONE WAS RECOVERED, AND FOUR EMBOLIZED TO THE LEFT HYPOGASTRIC ARTERY AND LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY. SNARE-BASED RETRIEVAL WAS ATTEMPTED WITH PARTIAL SUCCESS; COMPLETE EXTRACTION WAS NOT POSSIBLE. DUE TO THE PATIENT'S DETERIORATING CONDITION, NO FURTHER INTERVENTION WAS PERFORMED AT THAT TIME. ANOTHER CATHETER FROM THE SAME LOT FRAGMENTED UPON REMOVAL FROM THE PACKAGING DURING THE SAME PROCEDURE. THE PATIENT DIED ON (B)(6) 2025. CAUSE OF DEATH WAS DOCUMENTED AS MULTI-ORGAN FAILURE. THE ATTENDING PHYSICIAN STATED THAT THE CATHETER FRAGMENTATION WAS NOT THE ULTIMATE CAUSE OF DEATH BUT CONTRIBUTED BY DELAYING
Patient problems: Foreign Body In Patient
MAUDE report 24021718 ↗MalfunctionJan 7, 2026Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING BRONCHIAL ARTERY INFUSION CHEMOTHERAPY AND EMBOLIZATION, THE DISTAL END OF THE ANGIOGRAPHIC CATHETER FRACTURED INTO MULTIPLE SEGMENTS INSIDE THE PATIENT'S BODY. IMMEDIATE RETRIEVAL WAS ATTEMPTED USING A SNARE DEVICE, WHICH REQUIRED SEVERAL HOURS. SEVERAL FRAGMENTS WERE SUCCESSFULLY REMOVED; HOWEVER, ONE RESIDUAL CATHETER SEGMENT REMAINS IN THE PATIENT'S ILIAC ARTERY. THE PATIENT IS CURRENTLY UNDER CLOSE OBSERVATION.
Patient problems: Foreign Body In Patient
MAUDE report 23995566 ↗InjuryJan 5, 2026Fracture; Material Separation
ACCOUNT REPORTED DURING A BILIARY DRAIN PLACEMENT FOR BILIARY OBSTRUCTION DUE TO POST HEPATICOJEJUNOSTOMY STENOSIS, AN ATTEMPT WAS MADE TO ADVANCE A CATHETER OVER THE WIRE INTO THE SMALL BOWEL IN ORDER TO PERFORM A WIRE EXCHANGE. THERE WAS RESISTANCE AT THE SITE OF OBSTRUCTION AND IT WAS NOTED THAT THE TIP OF THE CATHETER WAS BROKEN AND UPON REMOVING THE CATHETER FROM THE PATIENT, THE TIP OF THE CATHETER REMAINED IN THE PATIENT. NO SNARES WERE AVAILABLE, THEREFORE THE CATHETER FRAGMENT WAS LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 23967593 ↗MalfunctionDec 30, 2025Material Separation; Material Separation
DURING A PERCUTANEOUS EMBOLIZATION PROCEDURE OF THE UTERINE ARTERY, THE 'FLOPPY' PART OF A CATHETER DETACHED. THESE FRAGMENTS, MOVIED FROM THE LEFT EXTERNAL ILIAC ARTERY TO THE POPLITEAL BIFURCATION OF THE ANTERIOR TIBIAL ARTERY. DURING RETRIEVAL ATTEMPTS, THE CATHETER STUMP FRAGMENTED INTO MULTIPLE SMALLER PIECES WHICH REQUIRED ADDITIONAL PROCEDURES AND TRANSFER TO ANOTHER FACILITY TO STABILIZE THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 23923569 ↗InjuryDec 19, 2025Fracture; Fracture
ACCOUNT REPORT THAT DURING A PROCEDURE THE BLACK SECTION OF CATHETER SNAPPED OFF INSIDE THE PATIENT. IT WAS RETRIEVED WITH A SNARE. NO PATIENT INJURY.
Patient problems: Foreign Body In Patient
MAUDE report 23850292 ↗InjuryDec 17, 2025Fracture; Fracture
ACCOUNT REPORTED AN 86 YO MALE PATIENT UNDERWENT LOWER LIMB ARTERIAL BALLOON ANGIOPLASTY AND ARTERIAL PLAQUE ROTATIONAL ATHERECTOMY. DURING FEMORAL ARTERY ANGIOGRAPHY, THE INTRAVASCULAR ANGIOGRAPHY CATHETER SUDDENLY BROKE. IT WAS IMMEDIATELY RETRIEVED WITH A SNARE DEVICE, AND ONE SECTION OF THE CATHETER WAS REMOVED. IT WAS DISCOVERED THAT THE REMAINING CATHETER INSIDE THE VESSEL WAS STILL FRACTURED. AFTER REPEATED RETRIEVAL ATTEMPTS, THE SURGERY WAS EVENTUALLY COMPLETED.
Patient problems: Foreign Body In Patient
MAUDE report 23830654 ↗InjuryDec 17, 2025Fracture; Fracture
ACCOUNT REPORT THAT DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) FOR ABDOMINAL AORTIC ANEURYSM. THE OPERATOR INSERTED THE IMPRESS CATHETER ALONG THE RADIFOCUS¿ GUIDE WIRE. THAT WIRE WAS EXCHANGED FOR THE LUNDERQUIST WIRE. WHILE ATTEMPTING TO REMOVE THE IMPRESS CATHETER, IT'S TIP (APPROXIMATELY 10 CM IN LENGTH) BROKE OFF. ATTEMPTS TO RETRIEVE THE TIP WERE UNSUCCESSFUL AND THE PROCEDURE WAS TERMINATED WITH THE BROKEN FRAGMENT REMAINING BETWEEN THE STENT GRAFT AND THE ANEURYSM WALL, INSIDE THE ANEURYSM.
Patient problems: Foreign Body In Patient
MAUDE report 23830640 ↗
Other Merit Medical Systems, Inc. products
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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