MiraFlex G43115Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10827002431154), received between Oct 6, 2016 and Aug 27, 2020 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2020Material Separation; Material Separation

  IT WAS REPORTED A (B)(6) YEAR OLD PATIENT REQUIRED A MIRA-FLEX MICROCATHETER FOR AN ANGIOGRAPHY PROCEDURE. WHEN THE OPERATOR INJECTED CONTRAST, THE HUB AND STRAIN RELIEF SEPARATED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10462385 ↗
• MalfunctionAug 20, 2020Material Separation; Material Separation

  IT WAS REPORTED A (B)(6) YEAR-OLD MALE PATIENT REQUIRED A MIRA-FLEX MICROCATHETER DURING A LIVER TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURE. THE OPERATOR REPORTED THAT "WHEN INJECTING WITH THE INJECTOR, THE TIP OF THE MICROCATHETER WAS SEPARATED FROM THE CATHETER". ANOTHER SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10432726 ↗
• MalfunctionAug 11, 2020Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10391370 ↗
• MalfunctionAug 10, 2020Material Separation; Material Separation

  IT WAS REPORTED A (B)(6) YEAR-OLD MALE PATIENT REQUIRED A MIRA-FLEX MICROCATHETER FOR HEPATIC ARTERY EMBOLIZATION. WHEN THE USER INSERTED THE MICROCATHETER INTO THE ANGIOGRAPHIC CATHETER, THE "HANDLE" OF THE MICROCATHETER DETACHED. THE MICROCATHETER WAS REMOVED AND REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE DEVICE WAS RETURNED ON 06AUG2020 AND SHOWED SEPARATION OF THE HUB FROM THE SHAFT OF THE CATHETER. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10384226 ↗
• MalfunctionAug 10, 2020Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10384053 ↗
• MalfunctionOct 18, 2019Material Separation; Material Separation

  IT WAS REPORTED A MALE PATIENT REQUIRED PLACEMENT OF A MIRA-FLEX MICROCATHETER FOR A LIVER TRANSARTERIAL CHEMOEMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE OPERATOR NOTICED "THE TIP OF THE MICROCATHETER WAS DETACHED" WHEN THEY PUSHED THE CHEMOTHERAPEUTIC DRUG THROUGH THE NEEDLE. THE DEVICE WAS REPLACED WITH A SIMILAR DEVICE TO FINISH THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9209894 ↗
• MalfunctionAug 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8859561 ↗
• MalfunctionApr 3, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A TRANSVASCULAR INTERVENTIONAL THERAPY PROCEDURE, THE PHYSICIAN ADVANCED THE MIRA-FLEX MICROCATHETER INTO THE SUPPLYING VESSELS OF THE TUMOR ALONG THE MICROWIRE GUIDE. WHEN INJECTING THE CONTRAST AGENT, THE PHYSICIAN FOUND THE WHITE TIP OF THE MICROCATHETER WAS DETACHED FROM HUB. THE PHYSICIAN REMOVED THE MICROCATHETER AND CHANGED TO A SIMILAR DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8477639 ↗
• MalfunctionAug 27, 2018Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT A MIRA-FLEX MICROCATHETER WAS PLACED IN THE LIVER OF A PATIENT WITH LIVER CANCER DURING A TACE PROCEDURE. AS THE MICROCATHETER WAS INSERTED INTO THE TARGET SITE TO DELIVER THE CONTRAST AGENT, THE TIP OF THE MICROCATHETER BECAME DETACHED. THE PHYSICIAN REPLACED THE CATHETER WITH A LIKE DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818728 ↗
• MalfunctionAug 27, 2018Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT A MIRA-FLEX MICROCATHETER WAS PLACED IN THE LIVER OF A PATIENT WITH CIRRHOSIS DURING A TACE PROCEDURE. AS THE MICROCATHETER WAS INSERTED INTO THE TARGET SITE TO DELIVER THE CONTRAST AGENT, THE TIP OF THE MICROCATHETER BECAME DETACHED. THE PHYSICIAN REPLACED THE CATHETER WITH A LIKE DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818335 ↗
• MalfunctionNov 1, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE CONNECTION (HUB) OF THE MICROCATHETER WAS NOTED TO BE DETACHED OUTSIDE OF THE PATIENT'S BODY ONCE THE USER INJECTED THE PVA. THIS OCCURRED DURING A TACE (TRANSARTERIAL CHEMOEMBOLIZATION) OF THE LIVER. THE DEVICE WAS REPLACED WITH A NEW DEVICE TO FINISH THE PROCEDURE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT OR INTERVENTION TAKEN AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6994513 ↗
• MalfunctionNov 1, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE SURGEON BEGAN TO INJECT THE PVA FOAM EMBOLIZATION PARTICLES DURING THE TACE (TRANSARTERIAL CHEMOEMBOLIZATION) PROCEDURE IN THE LIVER AND THEN THE JUNCTION OF CATHETER DETACHED. THE DEVICE WAS REPLACED WITH A NEW DEVICE TO FINISH THE PROCEDURE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT, NO SECTIONS OF THE DEVICE REMAINING INSIDE THE PATIENT BODY, AND NO ADDITIONAL PROCEDURES REQUIRED AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6994334 ↗
• MalfunctionNov 1, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE SURGEON BEGAN TO INJECT THE PVA FOAM EMBOLIZATION PARTICLES WHEN THE MICROCATHETER REACHED THE DESIRED POSITION DURING THE TACE (TRANSARTERIAL CHEMOEMBOLIZATION) PROCEDURE IN THE LIVER. SUBSEQUENTLY, THE JUNCTION OF CATHETER DETACHED. THE DEVICE WAS REPLACED WITH A NEW DEVICE TO FINISH THE PROCEDURE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT, NO SECTIONS OF THE DEVICE REMAINING INSIDE THE PATIENT BODY, AND NO ADDITIONAL PROCEDURES REQUIRED AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6994307 ↗
• MalfunctionNov 1, 2017Break; Detachment Of Device Component

  A HEPATIC ARTERIAL EMBOLIZATION PROCEDURE WAS PERFORMED FOR A LIVER CANCER PATIENT. THE SURGERY EMBOLIZED WITH INJECTION WHICH MIXED WITH OXALIPLATIN INJECTION AND PINGYANGMYCIN LIPIODOL EMULSION. AT THIS TIME, THE TAIL END (HUB) OF MICROCATHETER DETACHED. THE BREAKAGE HAPPENED OUTSIDE OF THE PATIENT'S BODY . THE SURGEON WITHDREW THE CATHETER AND REPLACED IT WITH A NEW DEVICE TO FINISH THE PROCEDURE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT OR ADDITIONAL PROCEDURES AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6994258 ↗
• MalfunctionOct 31, 2017Detachment Of Device Component

  DURING THE TRANS-CATHETER ARTERIAL CHEMOEMBOLIZATION (TACE), THE CONNECTION OF THE MICRO CATHETER WAS FOUND DETACHED. IT WAS REPLACED WITH A NEW DEVICE TO FINISH THE PROCEDURE. THE USER WHO OPERATED THE PROCEDURE HAD MET THE SAME PROBLEM WHEN USING THE MICRO CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 6990790 ↗
• MalfunctionNov 9, 2016Material Separation; Material Separation

  IT WAS REPORTED DURING TRANS-CATHETER ARTERIAL CHEMOEMBOLIZATION THE CONNECTION OF CATHETER WAS FOUND SEPARATED WHEN THE USER INJECTED THE MEDICINE. THE CATHETER WAS REPLACED WITH A NEW DEVICE TO FINISH THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, "THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6089632 ↗
• MalfunctionOct 6, 2016Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A (B)(6) OLD MALE WITH LIVER CANCER UNDERWENT A TRANSARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURE. THE USER INJECTED DOMESTIC IODIPIN AND THE TIP OF THE MICROCATHETER WAS FOUND DETACHED. THE DEVICE WAS REPLACED WITH A NEW DEVICE TO FINISH THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6004324 ↗