Renegade™ HI-FLO™ M001182880Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08714729280637), received between Oct 9, 2018 and Feb 19, 2026 — classified as 3 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Fracture

  IT WAS REPORTED THAT THE DEVICE FRACTURED. THIS RENEGADE? HI-FLO? INFUSION CATHETER WAS SELECTED FOR USE DURING A PROCEDURE TO TREAT A SPLENIC HEMORRHAGE. DURING THE PROCEDURE, THE CATHETER FRACTURED. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH A DIFFERENT DEVICE. THE EVENT WAS RESOLVED AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390110 ↗
• MalfunctionDec 11, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL OF THE LOWER LIMBS. A 135/10 RENEGADE HI FLO WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE DISTAL END OF THE MICROCATHETER BASE HAS A DISCONNECTION AND WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778822 ↗
• MalfunctionApr 11, 2025Difficult to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. PATIENT WAS PRESENTED WITH HEMOPTYSIS. A 135/10 RENEGADE HI FLO WAS SELECTED FOR USE IN A PULMONARY AORTA. DURING PROCEDURE, DIFFICULTY IN MICROCATHETER DELIVERY WAS NOTED. WHEN REMOVED, IT WAS VISUALLY OBSERVED THAT THE HYDROPHILIC COATING AT THE TIP'S FRONT END HAD NOTICEABLY PEELED OFF. WHEN TOUCHED, THE DEVICE FELT OBVIOUSLY NOT SMOOTH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21829591 ↗
• MalfunctionApr 3, 2025Fracture; Difficult to Advance; Material Integrity Problem; Fracture; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT SHAFT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PULMONARY AORTA. A 135/10 RENEGADE HI FLO WAS USED FOR TREATMENT. DURING THE PROCEDURE, IT WAS DIFFICULT TO ADVANCE THE MICROCATHETER IN THE CATHETER. A VISUAL INSPECTION SHOWS THAT THE FRONT END OF THE MICROCATHETER WAS OBVIOUSLY UNEVEN AND THE REAR END OF THE MICROCATHETER WAS FRACTURED DURING ADVANCING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT STATUS WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762817 ↗
• MalfunctionNov 15, 2024Defective Device; Material Deformation; Defective Device; Material Deformation

  IT WAS REPORTED THAT MARKERBAND ISSUE OCCURRED. A 135/10 RENEGADE HI-FLO WAS SELECTED FOR USE IN THE INTERVENTIONAL THERAPY FOR LIVER CANCER. DURING THE PROCEDURE, THE MARK POINT WHICH IS A RADIOGRAPHICALLY OPAQUE MARKER USED FOR LOCALIZATION WAS FOUND TO BE ABNORMAL. THE MICROCATHETER PRESSED AGAINST THE MICRO GUIDEWIRE CAUSING THE MARK POINT TO BE OUT OF POSITION. THE GUIDEWIRE AND MICROCATHETER WERE WITHDRAWN AND THE MICROCATHETER WAS FOUND TO BE KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20698452 ↗
• MalfunctionSep 30, 2024Break; Difficult to Remove; Difficult to Advance; Break; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED, AND THE DEVICE WAS DIFFICULT TO REMOVE. TWO 135/10 RENEGADE HI-FLO CATHETERS WERE SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED. DURING THE PROCEDURE, BOTH CATHETERS WERE RESISTANT DURING USE AND UPON REMOVAL. SHAFT DAMAGE WAS OBSERVED, BUT EACH DEVICE WAS REMOVED FROM THE PATIENT IN ONE PIECE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRD 135/10 RENEGADE HI-FLO CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20338670 ↗
• MalfunctionSep 30, 2024Break; Difficult to Remove; Difficult to Advance; Break; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED, AND THE DEVICE WAS DIFFICULT TO REMOVE. TWO 135/10 RENEGADE HI-FLO CATHETERS WERE SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED. DURING THE PROCEDURE, BOTH CATHETERS WERE RESISTANT DURING USE AND UPON REMOVAL. SHAFT DAMAGE WAS OBSERVED, BUT EACH DEVICE WAS REMOVED FROM THE PATIENT IN ONE PIECE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRD 135/10 RENEGADE HI-FLO CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20338225 ↗
• MalfunctionAug 23, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE COATING PEELED OFF. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 135/10 RENEGADE HI-FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS FLUSHED, AND IT WAS NOTED THAT THE HYDROPHILIC COATING PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20046292 ↗
• InjurySep 14, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT VASOSPASM OCCURRED. THE TARGET LESION WAS IN THE MILDLY CALCIFIED LIVER VESSEL. THE BLOOD VESSEL HAD TWO OPPOSITE CURVATURES VERY CLOSE TO EACH OTHER, ESPECIALLY THE FIRST ONE WHICH WAS NEARLY 90 DEGREES. A 135/10 RENEGADE HI FLO WAS SELECTED FOR USE. AFTER A LIVER PROCEDURE, THE PATIENT UNDERWENT HEPATIC ARTERIOGRAPHY AND PROPER HEPATIC ARTERY CHEMOEMBOLIZATION DUE TO INTERVENTIONAL THERAPY FOR MALIGNANT TUMOR AND LIVER MALIGNANT TUMOR. THIS DEVICE WAS NEEDED FOR HEPATIC ARTERIAL INFUSION CHEMOTHERAPY. THE CHARGE NURSE TOOK OUT THE MICROCATHETER WITH COMPLETE OUTER PACKAGE, AND AFTER THE PHYSICIAN SUCCESSFULLY SELECTED THE HEPATIC ARTERY BRANCH ACCORDING TO THE NORMAL OPERATION STEPS, THE OPERATOR TRIED TO FOLLOW IT UP WITH THE MICROCATHETER. THE MICROCATHETER COULD NOT BE ADVANCED AND FAILED MANY TIMES. AFTER THE FIRST CURVATURE WAS CROSSED, IT WAS DIFFICULT TO IMMEDIATELY CROSS THE NEXT ONE AT AN OPPOSITE ANGLE, AND THE CATHETER TIP WAS EASY TO STICK AGAINST THE BLOOD VESSEL WALL. IT WAS FOUND THAT THE PATIENT HAD VASCULAR SPASM WHICH MADE IT IMPOSSIBLE TO CONTINUE THE HEPATIC ARTERY EMBOLIZATION. AFTER USE, THE BLOOD VESSEL GOT WRINKLED AND SPASMODIC. THE H

  Patient problems: Vasoconstriction

  MAUDE report 17747123 ↗
• MalfunctionSep 7, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER AREA. A RENEGADE HI-FLO CATHETER INFUSION WAS SELECTED FOR USE. UPON UNPACKING, IT WAS NOTED THAT THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17703510 ↗
• MalfunctionAug 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE MICROCATHETER WAS FRACTURED. A 135/10 RENEGADE HI-FLO WAS SELECTED FOR EMBOLIZATION OF RENAL ARTERY. DURING PREPARATION, IT WAS NOTED THAT THE MICROCATHETER WAS FRACTURED AFTER UNPACKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498335 ↗
• MalfunctionAug 4, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A DEVICE SEPARATION OCCURRED. A 135CMX10CM RENEGADE HI FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT A SEPARATION OF THE HYDROPHILIC COATING WAS SEEN NEAR THE ENTRY PORT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RENEGADE HI FLO. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17461757 ↗
• MalfunctionMay 18, 2023Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25APR2023. IT WAS REPORTED THAT THE HEAD END CONNECTOR WAS SEPARATED. A 135/10 RENEGADE HI-FLO WAS SELECTED FOR HEPATIC ARTERIOGRAPHY EMBOLIZATION. DURING UNPACKING, IT WAS NOTED THAT THE HEAD END CONNECTOR WAS SEPARATED AT ABOUT 1.5CM FROM THE HUB. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A DEVICE FRACTURE LOCATED 2CM FROM THE HUB AND 33.8CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16952598 ↗
• MalfunctionApr 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS FRACTURED. A 135/10 RENEGADE HI FLO MICROCATHETER WAS SELECTED FOR USE IN THE LIVER ARTERY. DURING PREPARATION, IT WAS NOTED THAT THE TIP OF THE CATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743936 ↗
• MalfunctionMar 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TIP SEPARATION OCCURRED. A 135/10 RENEGADE HI FLO WAS SELECTED FOR USE. DURING THE PREPARATION, IT WAS NOTED THAT THE TIP JOINT WAS SEPARATED. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584914 ↗
• MalfunctionFeb 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. A 135/10 RENEGADE HI-FLO WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE MICROCATHETER FRACTURED WHEN REMOVING IT FROM THE HIVE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16396341 ↗
• MalfunctionJan 3, 2023Entrapment of Device; Defective Device; Entrapment of Device; Defective Device

  IT WAS REPORTED THAT THE CATHETER HAD A HOLE. A 135/10 RENEGADE HI-FLO WAS SELECTED FOR USE INTO THE LEFT HEPATIC ARTERY FOR PRE-Y90 MAPPING. DURING THE PROCEDURE, WHEN TRYING TO ADVANCE THE FATHOM MICROWIRE DOWN THE RENEGADE, THE WIRE WOULD NOT COME OUT THE DISTAL TIP AND A LOT OF RESISTANCE WAS NOTED ONLY FROM THE WIRE. THE WIRE AND RENEGADE WERE PULLED OUT AND IT WAS NOTED THAT A HOLE HAD DEVELOPED IN THE SIDE OF THE MICROCATHETER TOWARDS THE DISTAL END. THE FATHOM WIRE WAS PASSED THROUGH THE RENEGADE AT LEAST 3 OR 4 TIMES WITH NO ISSUE PRIOR. ONLY ONE POWER INJECTION WAS PERFORMED THROUGH THE RENEGADE AT A RATE OF 2 ML/S FOR 6 ML AT 600 PSI. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW MICROCATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16088341 ↗
• InjurySep 19, 2022Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT VASOSPASM OCCURRED. A 135/10 RENEGADE HI-FLO WAS USED TO SELECT BRANCH SMALL VESSELS DURING TACE PROCEDURE FOR INTERVENTIONAL TREATMENT AND WAS USED FOR CROSS CIRCUITY NARROW BLOOD VESSELS. DURING THE PROCEDURE, IT WAS NOTED THAT DUE TO THE UNEVEN DIAMETER AND THICKNESS OF MICROCATHETER THAT DID NOT REACH THE SPECIFIED PARAMETERS, THE DEVICE COULD NOT CROSS THE NON-BOSTON SCIENTIFIC 4F CATHETER. HENCE, THE PHYSICIAN COULD ONLY USE THE 4F CATHETER IN THE REMOTE OPERATION WHICH LED TO THE INCREASED RISK OF COMPLICATIONS OF THE PROCEDURE. THE DEVICE WAS DIRECTLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. VASOSPASM OCCURRED THAT LED TO AN INCREASED RISK OF COMPLICATIONS OF THE PROCEDURE.

  Patient problems: Vasoconstriction

  MAUDE report 15446972 ↗
• MalfunctionJan 27, 2022Break; Break

  IT WAS REPORTED THAT THE CATHETER BROKE. A 135/10 RENEGADE HI FLO WAS SELECTED FOR USE. DURING THE PREPARATION, IT WAS NOTED THAT THE CATHETER BROKE AS IT WAS TAKEN OUT FROM THE HOOP AFTER FLUSHING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367447 ↗
• MalfunctionNov 12, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE HYDROPHOBIC COATING FELL OFF. A 135/10 RENEGADE HI-FLO WAS SELECTED FOR USE. DURING UNPACKING, THE DEVICE WAS FLUSHED WITH STERILE INJECTION WATER. WHEN THE DEVICE WAS TAKEN OUT, IT WAS NOTED THAT THE HYDROPHOBIC COATING FELL OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804553 ↗
• MalfunctionSep 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE SEPARATED. A 135/10 RENEGADE HI FLO WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE CATHETER WAS SEPARATED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526902 ↗
• MalfunctionMay 13, 2021Entrapment of Device; Stretched; Difficult to Advance; Entrapment of Device; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE RENEGADE WAS STUCK AND COULD NOT BE REMOVED FROM THE IMAGER. A 135/10 RENEGADE HI-FLO AND A IMAGER II ANGIOGRAPHIC CATHETER WERE SELECTED FOR USE AS ANCILLIARY DEVICES FOR A PRECLINICAL STUDY FOR LIQUID EMBOLIC PROTOTYPES. DURING PROCEDURE, RENEGADE MICROCATHETER WAS PLACED THROUGH A IMAGER LL ANGIOGRAPHIC CATHETER. ONCE PASSED OUT THE TIP OF THE IMAGER, THE RENEGADE WAS UNABLE TO BE ADVANCED TO THE LOCATION. THE RENEGADE APPEARED TO BE LOCKED WITHIN THE IMAGER LL ANGIOGRAPHIC CATHETER AND WAS UNABLE TO BE ADVANCED TO THE TREATMENT SITE. THE RENEGADE WAS PULLED PRETTY FIRM TRYING TO GET IT BACK INTO THE IMAGER CATHETER AND IT BECAME STRETCHED. THE DEVICE WAS AGGRESSIVELY PULLED OUT IN TRYING TO SEPARATE THE TWO DEVICES AND THIS OCCURRED BOTH INSIDE AND OUTSIDE THE BODY. HOWEVER, THE RENEGADE COULD NOT BE REMOVED FROM THE IMAGER AND RENEGADE HAD TO BE CUT. THE PROCEDURE WAS COMPLETED WITH A NEW IMAGER LL AND RENEGADE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11823708 ↗
• InjuryMay 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RO MARKER DETACHED FROM THE TIP OF THE CATHETER AND TRAVELLED DOWN THE GASTRODUODENAL ARTERY (GDA). THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS HEPATIC ARTERY IN THE LIVER. A 135/10 RENEGADE HI-FLO CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE RO MARKER OF THE RENEGADE HI-FLO SLIPPED OFF OF THE TIP OF THE CATHETER. THE RO MARKER TRAVELLED DOWN THE GASTRODUODENAL ARTERY (GDA). THE CATHETER WAS REMOVED INTACT WITH THE RO MARKER REMOVED OVER THE WIRE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797867 ↗
• MalfunctionNov 24, 2020Break; Break

  IT WAS REPORTED THAT THE CATHETER WAS FRACTURED. A 135/10 RENEGADE HI-FLO KIT WAS SELECTED FOR USE. DURING THE COURSE OF THE PROCEDURE, IT WAS NOTED THAT THE CATHETER BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10897291 ↗
• MalfunctionAug 3, 2020Break; Break

  IT WAS REPORTED THAT THE MICROCATHETER WAS FRACTURED. A 135/10 RENEGADE HI-FLO KIT WAS SELECTED FOR USE IN AN EMBOLIZATION OF HEPATIC HEMANGIOMA. DURING THE PROCEDURE, WHEN THE PHYSICIAN UNPACKED THE PACKAGE AND AFTER SUFFICIENT FLUSHING WAS DONE, IT WAS NOTED THAT THE MICROCATHETER WAS FRACTURED WHEN IT WAS REMOVED FROM THE CARRIER HOOP. THE DEVICE DID NOT ENTER THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 10359427 ↗