Impress® 00884450009222Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00884450009222), received between Nov 27, 2019 and Oct 15, 2025 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (17 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR), AFTER PLACING THE STENT GRAFT AND REMOVING THE IMPRESS CATHETER IT WAS FOUND THAT THE TIP HAD COME OFF. WHEN THE GUIDEWIRE WAS REMOVED, THE TIP OF THE CATHETER WAS ENTANGLED IN THE GUIDEWIRE. THE OPERATOR HAS NO RECOLLECTION OF EXCESSIVE MANIPULATION OF THE IMPRESS. WHILE IMPRESS CATHETERS HAVE BEEN USED IN SIMILAR CASES, THIS INCIDENT WAS THE FIRST OCCURRENCE AT THE CUSTOMER FACILITY. NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294638 ↗
• InjuryFeb 6, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ENDO VASCULAR AORTIC REPAIR [EVAR] PROCEDURE, A CATHETER TIP DETACHED IN THE PATIENT'S DESCENDING ABDOMINAL AORTA. EXCESSIVE FORCE WAS NOT USED DURING CATHETER MANIPULATIONS. THE FOREIGN BODY WAS SUCCESSFULLY EXTERNALIZED VIA BALLOON CAPTURE TECHNIQUE, LIBERATING THE VESSEL ALONG WITH ALL RESIDUAL INTERVENTIONAL EQUIPMENT. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18655608 ↗
• InjuryAug 7, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL INTERVENTION, THE CATHETER BROKEN INTO TWO PARTS. WHILE INJECTING CONTRAST, THE PHYSICIAN ROTATED THE CATHETER TO CHANGE THE IMAGE ANGLE AND AT THAT POINT THE TIP DETACHED. A SNARE WAS USED TO REMOVE THE TIP FROM THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17475745 ↗
• InjuryJul 12, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING PERIPHERAL VASCULAR ARTERIOGRAPHY, THE CATHETER TIP DETACHED WITHIN A PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S ILIO-FEMORAL CONDUIT WITH A GUIDEWIRE AND A 5F CATHETER. DURING OVER-THE-WIRE CATHETER MANIPULATIONS UNDER FLUOROSCOPY WITHIN THE PATIENT'S COMMON ILIAC ARTERY. THE FOREIGN BODY REMAINED WITHIN THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17309363 ↗
• MalfunctionMar 2, 2023Flushing Problem

  WE HAVE A 5 FRENCH IMPRESS BERT CATHETER THAT WOULD NOT FLUSH, SO I DON'T KNOW IF THERE'S JUST NOT A HOLE OR WHAT.

  Patient problems: Insufficient Information

  MAUDE report 16466912 ↗
• InjuryOct 25, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE TIP OF THE CATHETER DETACHED INSIDE THE VESSEL. THE PROCEDURE WAS CHANGED TO CLASSICAL SURGERY FOR DEVICE RECOVERY. WHILE REMOVING THIS TIP OF THE CATHETER, THE SURGEON NOTICED THAT THE TIP CRUMBLED WHEN ATTEMPTED TO TOUCH IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15671011 ↗
• InjuryMay 4, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A NEUROVASCULAR PROCEDURE, THE DEVICE BROKE AND SEPARATED WHILE WITHIN THE PATIENT. THE CLINICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE BROKEN PIECE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14282364 ↗
• InjuryMay 4, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A NEUROVASCULAR PROCEDURE, THE DEVICE BROKE AND SEPARATED WHILE WITHIN THE PATIENT. THE CLINICIAN WAS UNABLE TO SUCCESSFULLY RETRIEVE THE PIECES AND REQUESTED ADDITIONAL HELP FROM ANOTHER CLINICIAN. THE CLINICIANS, TOGETHER, WERE ABLE TO SUCCESSFULLY REMOVE THE BROKEN PIECE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14282363 ↗
• InjuryApr 7, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL INTERVENTION PROCEDURE, THE CATHETER BROKE INTO 2 PIECES WITHIN THE PATIENT. THE CLINICAN WAS ABLE TO SUCCESSFULLY RETRIEVE THE BROKEN PIECE FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14048248 ↗
• InjuryNov 30, 2021Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY LIBERATING THE VASCULATURE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12905751 ↗
• InjuryJun 16, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE, THE TIP OF THE DEVICE WAS FRACTURED AND LEFT IN THE PATIENT'S BODY, WHICH WAS REMOVED FROM THE BODY BY A CAPTURE DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12009887 ↗
• InjuryFeb 23, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ABDOMINAL STENT GRAFT PROCEDURE, A 5 CM PORTION OF THE CATHETER TIP DETACHED WITHIN THE PATIENT YET REMAINED ON THE GUIDEWIRE. A VASCULAR SNARE DEVICE WAS INSERTED FROM CONTRALATERAL SIDE AND THE FOREIGN BODY WAS SUCCESSFULLY CAPTURED AND RETRIEVED WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364870 ↗
• InjuryFeb 23, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT A 5 CM PORTION OF THE CATHETER TIP DETACHED WITHIN THE PATIENT. A VASCULAR SNARE DEVICE WAS INSERTED AND THE FOREIGN BODY WAS SUCCESSFULLY CAPTURED AND RETRIEVED WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364864 ↗
• InjuryJan 26, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY [PTA] PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE FOREIGN BODY MIGRATED FURTHER INTO THE PATIENT'S ARTERY. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE FOREIGN BODY FROM THE PATIENT WITHOUT SUCCESS. THE PATIENT IS SCHEDULED FOR SURGICAL REMOVAL OF THE FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11233425 ↗
• InjuryJan 3, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL PERIPHERAL VASCULAR ANGIOPLASTY [PTA] PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S COMMON ILIAC BIFURCATION WITH A GUIDEWIRE AND THE 4F CATHETER. DURING A CATHETER EXCHANGE OVER-THE-WIRE WITHIN THE PATIENT'S COMMON ILIAC ARTERY, THE CATHETER TIP DETACHED AND REMAINED ON THE GUIDE WIRE. THE PHYSICIAN USED A 6F CATHETER TO SUCCESSFULLY [STOVE-PIPE] CAPTURE AND RETRIEVE THE 4F CATHETER TIP FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL BUT THE PROCEDURE HAD TO BE RESCHEDULED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9549086 ↗
• InjuryDec 20, 2019Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY [PTA] PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S COMMON ILIAC BIFURCATION WITH A GUIDEWIRE AND THE 4F CATHETER. DURING CATHETER REMOVAL THE CATHETER TIP DETACHED WITHIN THE PATIENT'S ARTERY. THE PHYSICIAN USED TWO VASCULAR SNARE DEVICES' TO SUCCESSFULLY RETRIEVE THE CATHETER TIP FROM THE PATIENT'S PERIPHERY WITH NO ADDITIONAL ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9501076 ↗
• MalfunctionDec 13, 2019Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY [PTA] PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY RETRIEVE THE CATHETER TIP FROM THE PATIENT. PROLONGATION OF HOSPITALIZATION WAS REQUIRED FOR THIS PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9469367 ↗
• InjuryNov 27, 2019Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A VARICOCELE EMBOLIZATION PROCEDURE, VASCULAR ACCESS GAINED AT THE RIGHT INTERNAL JUGULAR VEIN UNDER ULTRASOUND GUIDANCE. A 5FRENCH SHEATH WAS INSERTED FOR PROCEDURAL INTERVENTION. A 5F 100CM CATHETER WAS ADVANCED INTO THE LEFT INTERNAL SPERMATIC VEIN. THE TIP OF CATHETER SUCCESSFULLY OPACIFIED THE DISTAL LEFT INTERNAL SPERMATIC VEIN. EMBOLIZATION COILS WERE DEPLOYED AT THE INGUINAL REGION AS PLANNED. DURING AN ATTEMPT TO DEPLOY A 6TH COIL, RESISTANCE WAS EXPERIENCED. THE PHYSICIAN WAS UNABLE TO DEPLOY THE 6TH COIL DESPITE MULTIPLE ATTEMPTS. THE DECISION WAS MADE TO EXTRACT THE CATHETER AND DEPLOY THE COIL DIRECTLY THROUGH THE ACCESS SHEATH. SOME RESISTANCE WAS FELT DURING CATHETER REMOVAL. THE CATHETER TIP FRACTURED ACCIDENTLY DEPLOYING THE COIL WITHIN THE PATIENT'S RIGHT ATRIUM. SEVERAL ATTEMPTS TO RETRIEVE FRAGMENTED COIL FAILED. MIGRATION AND DISTAL EMBOLIZATION INTO THE RIGHT PULMONARY ARTERY WERE POSSIBLE. THE PATIENT WAS EMERGENTLY TRANSFERRED TO A SISTER HOSPITAL FOR FURTHER INTERVENTION AND FOREIGN BODY REMOVAL. THE COIL AND THE CATHETER TIP WERE SUCCESSFULLY RETRIEVED WITH A VASCULAR SNARE DEVICE. THE PATIENT TOLERATED THE PROCEDURE WELL AN

  Patient problems: Foreign Body In Patient

  MAUDE report 9385093 ↗