PhenomTM 27 CatheterRecalls & reported problems across all models

We found 6 models of PhenomTM 27 Catheter by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 211 adverse event reports in the FDA's MAUDE database, received between Dec 3, 2019 and Sep 30, 2026 — classified as 6 deaths, 21 injuries, 184 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (135 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

Most reported PhenomTM 27 Catheter problems

PhenomTM 27 Catheter models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PhenomTM 27 Catheter FG15150-0615-1S

  Catheter, continuous flush
  2 deaths139 reports
• PhenomTM 27 Catheter FG15150-0615-1S

  Catheter, continuous flush
  4 deaths36 reports
• PhenomTM 27 Catheter FG15160-0615-1S

  Catheter, continuous flush
  17 reports
• PhenomTM 27 Catheter FG15150-0630-1S

  Catheter, continuous flush
  8 reports
• PhenomTM 27 Catheter FG15160-0615-1S

  Catheter, percutaneous
  7 reports
• PhenomTM 27 Catheter FG15150-0630-1S

  Catheter, continuous flush
  4 reports

Recent PhenomTM 27 Catheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Retraction Problem; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951805 ↗
• MalfunctionSep 28, 2026Material Deformation; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917640 ↗
• MalfunctionSep 28, 2026Material Deformation; Physical Resistance/Sticking

  Medtronic received a report that on (b)(6)2026, a flow diverter stent was planned to be implanted in the patient. When the (Jiushi Shenkang) FD-4.5-15 stent was advanced to the end of the Phenom catheter and was about to be fully delivered, detachment occurred. The stent was immediately replaced with another brand; however, detachment occurred again at the same position. The microcatheter was then replaced, and a new stent was used to complete the procedure successfully. The event cause is identified to the vessel might have had severe calcification, angulation, or significant stenosis, and predilation might not have been sufficient.  The microcatheter might have had insufficient support, preventing effective transmission of the pushing force. No adverse impact occurred to the patient. The reported device and any accessory devices were prepared as indicated in the instructions for use (IFU). No patient symptoms or complications were associated with this event. *** NOTE "predilution" was corrected to "predilation" in the 2026-Jun-22 CFDA event description narrative*** Additional information received reported that the lesion was located near the ophthalmic artery, measuring 4¿5 mm, a

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917618 ↗
• MalfunctionSep 24, 2026Break; Difficult to Remove; Retraction Problem; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883745 ↗
• MalfunctionSep 23, 2026Difficult to Advance; Unintended Movement

  Medtronic received a report that Xinkainuo 6F105 intermediate catheter + Xinwei 0.014-200 cm neuro guidewire were used. The Phenom27 was advanced under guidance of the neuro guidewire, and an attempt was made to pass through the neck of the giant aneurysm in the posterior communicating segment of the internal carotid artery and advance to the middle cerebral artery. The guidewire passed through the aneurysm neck smoothly, and the Phenom27 microcatheter was continued to be advanced. At this time, the tip end of the Phenom27 microcatheter herniated into the aneurysm sac, increasing tension, and the microcatheter formed a loop within the aneurysm, making smooth advancement impossible. After multiple adjustments and repeated attempts, the tip end of the Phenom27 could not smoothly pass through the aneurysm neck for further advancement. The operator replaced the Phenom27 catheter, and after deployment and adjustment, it advanced smoothly into position, completing Pipeline implantation. The reported device and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (IFU). No patient symptoms or complications were associated with this even

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869734 ↗
• MalfunctionSep 2, 2026Retraction Problem; Difficult to Advance; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50564380 ↗
• MalfunctionAug 31, 2026Unintended Movement; Physical Resistance/Sticking

  Additional information was received reporting that no causes or contributing factors for the event were identified. It was clarified that the reported issue of unstable was referring to catheter kickback. That high resistance occurred in the proximal section of the device. The catheter was flushed per the IFU during the procedure. The Pipeline did not jump during deployment. Multiple Pipelines were not used in the procedure. The catheter tip was not under stress.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50521684 ↗
• MalfunctionAug 11, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50213268 ↗
• MalfunctionJul 30, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50086710 ↗
• MalfunctionJun 22, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN IN THE DISTAL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED, LEFT PALOPHTHALMIC ANEURYSM WITH A MAX DIAMETER OF 8 MM AND AN 8 MM NECK DIAMETER. THE LANDING ZONE WAS 4.2 MM DISTALLY AND 5 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS SATISFACTORY. IT WAS REPORTED THAT ALL THE PREPARATION WAS FOLLOWED AS INDICATED IN THE PACKAGE INSERT. THE PIPELINE STENT AT THE TIME OF THE IMPLANTATION, DID NOT OPEN AT THE DISTAL PART. MANEUVERS OF REPOSITIONING, CORRECTION OF THE TENSION OF THE DELIVERY SYSTEM, AND OPENING AND RECAPPING OF THE SYSTEM STILL DID NOT OPEN THE STENT. THE STENT WAS REPLACED BY ANOTHER DEVICE. THE PIPELINE WAS STUCK IN THE CAPTURE COIL. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER, AND FROM THE PATIENT. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-LABEL). THE PIPELINE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25578482 ↗
• MalfunctionApr 27, 2026Unintended Movement; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE OCCURRED WHEN ADVANCING THE DISTAL TIP OF THE PHENOM IN THE GUIDE CATHETER. THERE WAS NO DAMAGE OBSERVED TO THE CATHETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS QUITE SEVERE WHICH CONTRIBUTED TO THE DEPLOYMENT DIFFICULTIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009017 ↗
• MalfunctionApr 24, 2026Retraction Problem; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED LEFT CLINOID C5 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 6.3 MM AND A 3.0 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH 7.8MM DIAMETER. THE LANDING ZONE WAS 3.1MM DISTALLY AND 4.0MM PROXIMALLY. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS NORMAL. IT WAS REPORTED THAT AFTER THE OPERATOR ESTABLISHED ACCESS, A PHENOM 27 MICROCATHETER WAS POSITIONED IN PLACE. A SHIELD PED400-18 DEVICE WAS UNPACKED AND HYDRATED. THE DISTAL END OF THE DEVICE WAS ADVANCED THROUGH THE Y-VALVE TO THE PROXIMAL/TAIL END OF THE PHENOM 27 MICROCATHETER. WHILE THE ASSISTANT ADVANCED THE DELIVERY WIRE TO ITS FULL EXTENT, VERY LITTLE RESISTANCE WAS NOTED. THE DISTAL END OF THE DEVICE WAS UNABLE TO ENTER THE PROXIMAL/TAIL END OF THE PHENOM 27 MICROCATHETER. THE OPERATOR THEN WITHDREW THE ENTIRE DEVICE ONTO THE TABLE AND ATTEMPTED TO ADVANCE THE DELIVERY WIRE BACK AND FORTH; HOWEVER, THE STENT REMAINED STATIONARY. IT WAS SUBSEQUENTLY NOTED THAT THE DEVICE HAD BECOME DETACHED (DEVICE DETACHMENT). THE OPERATOR THEN REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982553 ↗
• MalfunctionApr 20, 2026Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING ADVANCEMENT, A PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT ENCOUNTERED SEVERE RESISTANCE IN THE PHENOM 27 MICROCATHETER. THE STENT WAS DAMAGED AND FAILED TO OPEN, AND THE MICROCATHETER FRACTURED. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, C6 ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 8 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 4 MM DISTALLY AND 5 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 8 MM. THE ANGIOGRAPHIC RESULT POST PROCEDURE REPORTED C7 ANEURYSM. THE VESSEL SEGMENT FROM C7 TO C5 WAS TORTUOUS, RESULTING IN SIGNIFICANT RESISTANCE DURING STENT ADVANCEMENT. DURING STENT DEPLOYMENT, ELONGATION AND RELAXATION MANEUVERS WERE PERFORMED TO ADJUST WALL APPOSITION AT THE OUTER CURVE OF C6, THE STENT BECAME FLATTENED AND FAILED TO OPEN. ON THE THIRD ATTEMPT, THE STENT DELIVERY CATHETER FRACTURED, AND THE STENT WAS WITHDRAWN FROM THE BODY TOGETHER WITH THE P27 MICROCATHETER. THE PRODUCTS WERE REPLACED WITH A MEDTRONIC PRODUCTS TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925029 ↗
• MalfunctionApr 11, 2026Difficult to Advance; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT 2 PIPELINE FLEX WITH SHIELD TECHNOLOGY STENTS (PED2-425-35, PED2-450-25) FAILED TO OPEN AT THE MIDDLE AND DISTAL SECTIONS WHEN THE PROXIMAL, MIDDLE, AND DISTAL SECTIONS WERE POSITIONED IN A BEND. MORE THAN 50% OF EACH PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN, EACH WAS RESHEATHED MORE THAN 2 TIMES, AND NO ADDITIONAL STEPS OR OTHER DEVICES WERE REQUIRED TO OPEN THE PIPELINES. THE PIPELINES WERE RESHEATHED AND REMOVED WITH THE MICROCATHETER. AN ADDITIONAL PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT (PED2-425-30) REQUIRED ADJUNCTIVE BALLOON ANGIOPLASTY TO ENHANCE WALL APPOSITION. ADDITIONALLY, RESISTANCE WAS ENCOUNTERED AT THE DISTAL END OF THE PHENOM 27 MICROCATHETER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, RIGHT CAVERNOUS SEGMENT ANEURYSM WITH A MAX DIAMETER OF 4.3 MM AND A 6 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 3.9 MM DISTALLY AND 4.3 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. RIGHT INTERNAL CAROTID ARTERY (ICA) ACCESS VESSEL DIAMETER WAS 4.3 MM. DUAL ANTIPLATELET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847475 ↗
• MalfunctionApr 8, 2026Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE EXPERIENCED RESISTANCE WITHIN A PHENOM CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED ON THE C5 SEGMENT WITH A MAX DIAMETER OF 3.2 MM AND A 2.1 MM NECK DIAMETER. THE PATIENT HAS A DISTAL LANDING ZONE OF 3.78 MM AND A PROXIMAL OF 4.22 MM. IT WAS NOTED THE PATIENT'S ACCESS VESSEL DIAMETER ON THE FEMORAL ARTERY IS 8.9 MM AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT AFTER ADVANCING THE MICROCATHETER, THERE WAS RESISTANCE DURING STENT DELIVERY, AND IT COULD NOT BE POSITIONED C ORRECTLY. AFTER REMOVING BOTH THE STENT AND THE MICROCATHETER TOGETHER OUTSIDE THE BODY, IT WAS OBSERVED THAT THE STENT'S TIP END WAS FRAYED AND THE MICROCATHETER'S TIP END ALSO SHOWED ABNORMALITIES. DEVICES WERE FLUSHED AND PREPPED AS INDICATED BY THE IFU. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED. THE CAUSE OF THE RESISTANCE AND DAMAGE WERE NOT DETERMINED. THERE WAS NO DEVICE JUMP OR CATHETER TIP MOVEMENT DURING DEPLOYMENT. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821348 ↗

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