PhenomTM 21 Catheter FG13150-0615-2S (UDI 00763000399689)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000399689), received between Mar 7, 2023 and May 6, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Retraction Problem

  MEDTRONIC RECEIVED A REPORT OF TWO PIPELINE VANTAGE DEVICES THAT FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM LOCATED IN THE BASILAR ARTERY WITH A MAX DIAMETER OF 4.3MM AND A 5.3MM NECK DIAMETER. THE LANDING ZONE (ARTERY SIZE) WAS 1.3MM DISTAL AND 1.8MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. DAPT (DUAL ANTIPLATELET TREATMENT ) WAS ADMINISTERED WITH AN UNKNOWN PLATELET REACTIVITY UNITS (PRU) LEVEL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NONE. THERE ARE IMAGES AVAILABLE FOR REVIEW. IT WAS REPORTED THAT DURING FLOW-DIVERTING STENT IMPLANTATION FOR AN ANEURYSM, THE ANEURYSM WAS A FUSIFORM ANEURYSM LOCATED IN THE P2 SEGMENT. THE INTERMEDIATE CATHETER WAS IN PLACE, AND THE MICROCATHETER WAS POSITIONED APPROPRIATELY. A 250-14 STENT WAS SELECTED. AFTER DELIVERING THE STENT TO THE TARGET POSITION, THE TIP END OF THE STENT FAILED TO OPEN PROPERLY. DESPITE CONTINUED DEPLOYMENT, THE STENT REMAINED ROD-SHAPED. IT WAS RETRIEVED AND REDEPLOYED THREE TIMES IN AN ATTEMPT TO ACHIEVE OPENING, BUT IT STILL FAILED TO OPEN. THE MICROCATHETER AND STENT WERE REPLACED AND THE REPLACEMENTS WERE ADVANCED TO THE TARGET P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25104551 ↗
• InjuryDec 29, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THAT THE PATIENT DID HAVE CLIPPING BECAUSE THE PIPELINE TREATMENT FAILED EVEN THOUGH IT WAS PREVIOUSLY REPORTED THAT THERE WERE NO FUTURE PLANS FOR MEDICAL OR SURGICAL INTERVENTIONS FOR THE ANEURYSM AND NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23916983 ↗
• MalfunctionNov 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER DEPLOYMENT OF THE PIPELINE VANTAGE WITH SHIELD TECHNOLOGY STENT, RESISTANCE WAS MET WHEN ADVANCING THE PHENOM 27 MICROCATHETER ALONG THE PIPELINE DEVICE WIRE, AND THE WIRE COULD NOT BE FURTHER DRAWN INTO THE CATHETER STARTING FROM THE SECTION WITH THE PTFE SLEEVES, RESULTING IN TENSION. THE PUSHWIRE/CAPTURE COIL STUCK DURING RETRACTION AFTER THE PTFE SLEEVES ENTERED THE CATHETER. THE STENT WAS IMPLANTED AND THE CATHETER AND WIRE/TIP COIL WERE REMOVED FROM THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED WITH THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL). THE PUSHWIRE WAS NOT ROTATED DURING REMOVAL. IT IS UNKNOWN IF THERE WAS ANY DAMAGE TO THE CATHETER, PUSHWIRE, OR CAPTURE COIL. ANCILLARY DEVICES INCLUDE A 150 CM PHENOM 27 MICROCATHETER. THE PATIENT IS ALIVE AND THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE LESION CHARACTERISTIC WAS AN INTERNAL CAROTID ARTERY. VESSEL TORTUOSITY WAS MODERATE. THE CATHETER WAS FLUSHED PER IFU DURING THE PROCEDURE. THERE WAS NO FRICTION OR DIFFI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535668 ↗
• InjuryApr 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH A PED3 PIPELINE STENT AND PHENOM 21 CATHETER HAD STROKES. PATIENT UNDERWENT IMPLANTATION OF PIPELINE VANTAGE 3.5X16 ON (B)(6) 2024, WITHOUT COMPLICATIONS DURING THE PROCEDURE. ON (B)(6), SHE FAINTED AND WAS TAKEN TO HOSPITAL. THE DIAGNOSTIC INVESTIGATION REVEALED A HEMORRHAGIC STROKE. ON THE SAME DAY, SHE SUFFERED AN ISCHEMIC STROKE. ANGIOGRAPHY WAS CARRIED OUT WHILE SHE WAS IN HOSPITAL. HOSPITALIZATION AND SHOWED SEVERE HYPERPLASIA IN THE PIPELINE, RESULTING IN A STENOSIS OF 80/90% STENOSIS IN THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY. THE PATIENT UNDERWENT TREATMENT AND WAS DISCHARGED FROM HOSPITAL WITHOUT MOTOR DEFICITS ON (B)(6) 2025. THE PATIENT SUFFERED A HEMORRHAGIC STROKE 3 MONTHS AFTER THE VANTAGE PIPELINE WAS IMPLANTED, AND SOON AFTER, AN ISCHEMIC STROKE. IN THE INVESTIGATION, AN ANGIOGRAPHY WAS PERFORMED AND SHOWED A SEVERE HYPERPLASIA IN THE AREA WHERE THE PIPELINE WAS IMPLANTED, WITH ARTERIAL STENOSIS OF 80/90%. THE PATIENT RECEIVED DRUG TREATMENT TO CONTROL HYPERPLASIA. THE PATIENT WAS HOSPITALIZED FOR 12 DAYS AFTER THE HEMORRHAGIC STROKE. THERE WAS PERMANENT INJURY. SEVERE STENOSIS OF THE LEFT MIDDLE

  Patient problems: Hemorrhagic Stroke; Hyperplasia; Ischemia Stroke; Stenosis; Syncope/Fainting

  MAUDE report 21810969 ↗
• MalfunctionApr 2, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE WAS THE TORTUOUS ANATOMY WAS DUE TO THE CURVES, WHICH DID NOT ALLOW FOR THE DELIVERY OF THE DEVICE. WHEN THEY REMOVED THE MICROCATHETER WITH THE DIVERTER INSIDE, THEY MANIPULATED IT ON THE WORKBENCH, AND IT COULD BE PUSHED AND RECAPTURED (BUT ON THE WORKBENCH, WE DID NOT HAVE THE CURVES OR TENSIONS TO WHICH IT WAS EXPOSED IN THE PATIENT'S VASCULAR ANATOMY. RESISTANCE WAS FELT IN THE DISTAL PORTION AT THE TIME OF RELEASING THE DIVERTER; IT DID NOT RESPOND AND MOVED AS A BLOCK WHEN UNSHEATHING OR PUSHING THE DIVERTER'S PUSHER. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. EACH CATHETER HAD ITS HEPARINIZED IRRIGATION WITH AN INFUSER. DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER WAS OBSERVED, BUT IT WAS DUE TO THE FORCE OR TENSION APPLIED TO THE PUSHER WHEN TRYING TO ADVANCE THEDEVICE, NOT BEFORE ITS USE. THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE TIP OF THE CATHETER DID NOT MOVE DURING DEPLOYMENT. AFTER EXPOSING THE DISTAL COIL OF THE PUSHER, IT DID NOT RESPOND AND EVERYTHING MOVED AS A BLOCK. THE FLOW DIVERTER COULD NOT BE EXTERNALIZED OUT OF THE MICROCATHETER; IT NEVER EXITED THE MICROCATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753996 ↗
• MalfunctionSep 11, 2024Difficult to Advance; Unintended Movement; Difficult to Advance; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT A PHENOM ENCOUNTERED MOVEMENT DURING PLACEMENT OF THE PIPELINE (DIFFICULT PLACEMENT/POSITIONING) THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A RUPTURED RIGHT MCA ANEURYSM WITH A BLISTER MORPHOLOGY. ANEURYSM DIMENSIONS: MAX AND NECK DIAMETER N/A. LANDING ZONE (ARTERY SIZE): DISTAL 2.59 MM AND PROXIMAL 2.74 MM. THE PATIENT¿S VESSEL TORTUOSITY WAS MINIMAL. THE PHYSICIAN WAS TREATING A RUPTURED RIGHT MCA BIFURCATION BLISTER ANEURYSM VIA THIS PIPELINE VANTAGE FD. THEY USED CEREBASE DA LONG SHEATH <(>&<)> PHENOM PLUS DAC AS ACCESS PRODUCTS. THEN THEY TOOK PHENOM-21 MICROCATHETER OVER HYBRID-12/14 GUIDEWIRE TO PLACE IT DISTALLY IN RIGHT INFERIOR MCA BRANCH. AFTER PLACING PHENOM-21, THEY STARTED PUSHING THIS PIPELINE VANTAGE FD. WHEN THIS FD STARTED COMING IN RIGHT M1, PHENOM-21 STARTED COMING BACK RAPIDLY. PHYSICIAN PUSHED PHENOM PLUS TILL ICA BIFURCATION AND PHENOM-21 MORE DISTALLY. AGAIN THEY TRIED TO PUSH THIS PIPELINE VANTAGE AND THIS TIME IT REACHED TILL DISTAL MARKER OF PHENOM-21. AFTER OPENING APPX. 4-5MM OF FD, ENTIRE SYSTEM OF PHENOM PLUS, PHENOM-21 AND TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20191625 ↗
• MalfunctionMar 7, 2023Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A PED3 PIPELINE WAS STUCK IN A PHENOM 21 CATHETER. DURING THE PASSAGE OF THE FLOW DIVERTER INSIDE THE MICROCATHETER, THE HEALTHCARE PROVIDER (HCP) FEELS DIFFICULTY AND COMPLICATION THE INFUSION IS VERIFIED, THE ANGIOGRAPH IMAGES ARE VERIFIED AND IT IS DETERMINED THAT THE MICROCATHETER TRAPS THE DIVERTER, PREVENTING IT FROM PASSING. IT WAS STUCK IN THE PROXIMAL SECTION OF THE CATHETER DURING DELIVERY. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARANIZED SALINE. THE CATHETER WAS DAMAGED IN THE DISTAL SECTION. THE PUSHWIRE WAS NOT DAMAGED. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANOTHER FLOW DIVERTER WAS IMPLEMENTED. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, FUSIFORM ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA). IT WAS A MID CEREBRAL ANEURYSM. THE MAX DIAMETER WAS 2.8MM AND THE NECK DIAMETER WAS 3.2MM. THE DISTAL LANDING ZONE WAS 2.5MM AND THE PROXIMAL LANDING ZONE WAS 2.2MM. VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY WITH A DIAMETER OF 7MM. NO PATIENT INJURY OR SYMPTOMS WERE REPORTED.  ANCILLARY DEVICES: NAVIEN 058 LOT: B466156 NEW INFORMATION WAS RECEIVED. THE DOCTOR T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16498336 ↗