PIPELINERecalls & reported problems across all models
Micro Therapeutics, Inc. · 114 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one PIPELINE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 622
- Deaths reported
- 12
- Injuries reported
- 63
- Recalls
- 1
We found 114 models of PIPELINE by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 622 adverse event reports in the FDA's MAUDE database, received between Mar 25, 2016 and Jun 5, 2024 — classified as 12 deaths, 63 injuries, 547 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (419 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Reports received per month, all models
PIPELINE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 13, 2021Open, Classified
Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.
Z-2402-2021 · Root cause: Device Design · names 87 of these models · Recall details · FDA record ↗
Most reported PIPELINE problems
Device problems
- Activation Failure419
- Physical Resistance/Sticking161
- Break88
- Material Deformation70
- Adverse Event Without Identified Device or Use Problem31
- Unintended Movement25
- Detachment of Device or Device Component22
- Unintended Ejection17
Patient problems
- No Known Impact Or Consequence To Patient309
- No Clinical Signs, Symptoms or Conditions281
- Intracranial Hemorrhage12
- Device Embedded In Tissue or Plaque11
- Death10
- Fistula8
- Therapeutic Response, Decreased6
- Embolus4
PIPELINE models
114 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- PIPELINE PED-500-20Intracranial aneurysm flow diverter1 recall31 reports
- PIPELINE PED-500-35Intracranial aneurysm flow diverter1 recall1 death29 reports
- PIPELINE PED-500-16Intracranial aneurysm flow diverter1 recall2 deaths27 reports
- PIPELINE PED-500-25Intracranial aneurysm flow diverter1 recall1 death23 reports
- PIPELINE PED-500-30Intracranial aneurysm flow diverter1 recall21 reports
- PIPELINE PED-450-25Intracranial aneurysm flow diverter1 recall20 reports
- PIPELINE PED-475-30Intracranial aneurysm flow diverter1 recall1 death19 reports
- PIPELINE PED-400-25Intracranial aneurysm flow diverter1 recall17 reports
- PIPELINE PED-475-14Intracranial aneurysm flow diverter1 recall16 reports
- PIPELINE PED-450-35Intracranial aneurysm flow diverter1 recall1 death15 reports
- PIPELINE PED-500-18Intracranial aneurysm flow diverter1 recall15 reports
- PIPELINE PED-400-20Intracranial aneurysm flow diverter1 recall1 death14 reports
- PIPELINE PED-450-20Intracranial aneurysm flow diverter1 recall13 reports
- PIPELINE PED-450-18Intracranial aneurysm flow diverter1 recall12 reports
- PIPELINE PED-475-20Intracranial aneurysm flow diverter1 recall12 reports
- PIPELINE PED-475-25Intracranial aneurysm flow diverter1 recall1 death12 reports
- PIPELINE PED-425-16Intracranial aneurysm flow diverter1 recall11 reports
- PIPELINE PED-425-20Intracranial aneurysm flow diverter1 recall1 death11 reports
- PIPELINE PED-425-35Intracranial aneurysm flow diverter1 recall10 reports
- PIPELINE PED-450-14Intracranial aneurysm flow diverter1 recall10 reports
- PIPELINE PED-500-12Intracranial aneurysm flow diverter1 recall9 reports
- PIPELINE PED-400-16Intracranial aneurysm flow diverter1 recall8 reports
- PIPELINE PED-400-30Intracranial aneurysm flow diverter1 recall8 reports
- PIPELINE PED-425-25Intracranial aneurysm flow diverter1 recall8 reports
- PIPELINE PED-450-16Intracranial aneurysm flow diverter1 recall8 reports
- PIPELINE PED-450-30Intracranial aneurysm flow diverter1 recall8 reports
- PIPELINE PED-475-35Intracranial aneurysm flow diverter1 recall8 reports
- PIPELINE PED-375-14Intracranial aneurysm flow diverter1 recall7 reports
- PIPELINE PED-375-20Intracranial aneurysm flow diverter1 recall1 death7 reports
- PIPELINE PED-400-14Intracranial aneurysm flow diverter1 recall7 reports
- PIPELINE PED-450-12Intracranial aneurysm flow diverter1 recall7 reports
- PIPELINE PED-475-18Intracranial aneurysm flow diverter1 recall7 reports
- PIPELINE PED-375-35Intracranial aneurysm flow diverter1 recall6 reports
- PIPELINE PED-425-14Intracranial aneurysm flow diverter1 recall6 reports
- PIPELINE PED-475-12Intracranial aneurysm flow diverter1 recall6 reports
- PIPELINE PED-275-20Intracranial aneurysm flow diverter1 recall1 death5 reports
- PIPELINE PED-350-12Intracranial aneurysm flow diverter1 recall5 reports
- PIPELINE PED-375-30Intracranial aneurysm flow diverter1 recall5 reports
- PIPELINE PED-425-30Intracranial aneurysm flow diverter1 recall5 reports
- PIPELINE PED-475-10Intracranial aneurysm flow diverter1 recall5 reports
- PIPELINE PED-250-14Intracranial aneurysm flow diverter1 recall4 reports
- PIPELINE PED-350-18Intracranial aneurysm flow diverter1 recall4 reports
- PIPELINE PED-350-20Intracranial aneurysm flow diverter1 recall4 reports
- PIPELINE PED-375-16Intracranial aneurysm flow diverter1 recall4 reports
- PIPELINE PED-400-18Intracranial aneurysm flow diverter1 recall4 reports
- PIPELINE PED-425-18Intracranial aneurysm flow diverter1 recall4 reports
- PIPELINE PED-475-16Intracranial aneurysm flow diverter1 recall4 reports
- PIPELINE PED-275-18Intracranial aneurysm flow diverter1 recall3 reports
- PIPELINE PED-300-12Intracranial aneurysm flow diverter1 recall3 reports
- PIPELINE PED-300-30Intracranial aneurysm flow diverter1 recall3 reports
- PIPELINE PED-325-20Intracranial aneurysm flow diverter1 recall3 reports
- PIPELINE PED-350-30Intracranial aneurysm flow diverter1 recall3 reports
- PIPELINE PED-375-25Intracranial aneurysm flow diverter1 recall3 reports
- PIPELINE PED-400-10Intracranial aneurysm flow diverter1 recall3 reports
- PIPELINE PED-500-10Intracranial aneurysm flow diverter1 recall3 reports
- PIPELINE PED-250-16Intracranial aneurysm flow diverter1 recall2 reports
- PIPELINE PED-250-20Intracranial aneurysm flow diverter1 recall2 reports
- PIPELINE PED-300-18Intracranial aneurysm flow diverter1 recall2 reports
- PIPELINE PED-300-20Intracranial aneurysm flow diverter1 recall2 reports
- PIPELINE PED-300-35Intracranial aneurysm flow diverter1 recall2 reports
- PIPELINE PED-325-16Intracranial aneurysm flow diverter1 recall2 reports
- PIPELINE PED-325-30Intracranial aneurysm flow diverter1 recall2 reports
- PIPELINE PED-350-35Intracranial aneurysm flow diverter1 recall2 reports
- PIPELINE PED-250-10Intracranial aneurysm flow diverter1 recall1 report
- PIPELINE PED-275-12Intracranial aneurysm flow diverter1 recall1 report
- PIPELINE PED-275-14Intracranial aneurysm flow diverter1 recall1 report
- PIPELINE PED-300-14Intracranial aneurysm flow diverter1 recall1 report
- PIPELINE PED-300-16Intracranial aneurysm flow diverter1 recall1 report
- PIPELINE PED-325-25Intracranial aneurysm flow diverter1 recall1 report
- PIPELINE PED-350-10Intracranial aneurysm flow diverter1 recall1 report
- PIPELINE PED-350-16Intracranial aneurysm flow diverter1 recall1 report
- PIPELINE PED-350-25Intracranial aneurysm flow diverter1 recall1 report
- PIPELINE PED-375-10Intracranial aneurysm flow diverter1 recall1 report
- PIPELINE PED-425-10Intracranial aneurysm flow diverter1 recall1 report
- PIPELINE PED-450-10Intracranial aneurysm flow diverter1 recall1 report
- PIPELINE PED-250-12Intracranial aneurysm flow diverter1 recall0 reports
- PIPELINE PED-250-18Intracranial aneurysm flow diverter1 recall0 reports
- PIPELINE PED-275-10Intracranial aneurysm flow diverter1 recall0 reports
- PIPELINE PED-275-16Intracranial aneurysm flow diverter1 recall0 reports
- PIPELINE PED-300-10Intracranial aneurysm flow diverter1 recall0 reports
- PIPELINE PED-300-25Intracranial aneurysm flow diverter1 recall0 reports
- PIPELINE PED-325-10Intracranial aneurysm flow diverter1 recall0 reports
- PIPELINE PED-325-12Intracranial aneurysm flow diverter1 recall0 reports
- PIPELINE PED-325-14Intracranial aneurysm flow diverter1 recall0 reports
- PIPELINE PED-325-18Intracranial aneurysm flow diverter1 recall0 reports
- PIPELINE PED-325-35Intracranial aneurysm flow diverter1 recall0 reports
- PIPELINE PED-375-12Intracranial aneurysm flow diverter1 recall0 reports
- PIPELINE PED-500-14Intracranial aneurysm flow diverter1 death16 reports
- PIPELINE PED-425-12Intracranial aneurysm flow diverter6 reports
- PIPELINE PED-400-12Intracranial aneurysm flow diverter5 reports
- Pipeline PED-475-25Intracranial aneurysm flow diverter4 reports
- Pipeline PED-500-25Intracranial aneurysm flow diverter4 reports
- PIPELINE PED-400-35Intracranial aneurysm flow diverter4 reports
- Pipeline PED-425-20Intracranial aneurysm flow diverter2 reports
- Pipeline PED-450-20Intracranial aneurysm flow diverter2 reports
- Pipeline PED-475-16Intracranial aneurysm flow diverter2 reports
- Pipeline PED-375-35Intracranial aneurysm flow diverter2 reports
- Pipeline PED-425-25Intracranial aneurysm flow diverter2 reports
- Pipeline PED-450-25Intracranial aneurysm flow diverter2 reports
- Pipeline PED-450-35Intracranial aneurysm flow diverter2 reports
Recent PIPELINE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2024Material Deformation; Activation Failure; Material Deformation; Activation Failure
MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX STENT THAT FAILED TO OPEN AND WAS DAMAGED AT THE DISTAL END. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF A C7 POSTERIOR COMMUNICATING ARTERY SEGMENT UNRUPTURED SACCULAR LATERAL WALL ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 12MM AND THE NECK DIAMETER WAS 6.8MM. VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE MICROCATHETER WAS PASSED ACROSS THE ANEURYSM AND DEPLOYMENT OF THE PIPELINE STENT WAS INITIATED ACCORDING TO STANDARD PROCEDURE. AFTER TRYING TO OPEN THE PIPELINE STENT IN THE M1 STRAIGHT SEGMENT SEVERAL TIME, THE DISTAL END STILL COULD NOT BE OPENED SMOOTHLY SO IT WAS REMOVED FROM THE PATIENT'S BODY. AFTER TAKING OUT THE PIPELINE, IT WAS FOUND THAT THE DISTAL END OF THE STENT WAS DAMAGED. A PIPELINE SHIELD (MODEL: PED2-4.75-25) WAS THEN USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19471258 ↗InjurySep 28, 2023Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SECOND DEVICE WAS ALWAYS PLANNED GIVEN THE SIZE AND COMPLEXITY OF THE ANEURYSM.
Patient problems: Aneurysm
MAUDE report 17833218 ↗MalfunctionSep 25, 2023Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT WHEN THE MARKSMAN WAS USED TO DELIVER THE PIPELINE, THE PIPELINE COULD NOT BE PUSHED IN THE MIDDLE SEGMENT OF THE MARKSMAN. THE PIPELINE COULD NOT BE PUSHED DESPITE REPEATED ATTEMPTS. THE PIPELINE FAILED TO OPEN AT THE DISTAL END. THE PIPELINE WAS NOT POSITIONED IN A BEND. LESS THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN IT FAILED TO OPEN AND THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES. THE PIPELINE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE MARKSMAN WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT OPHTHALMIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 11MM AND A 5.3MM NECK DIAMETER. THE LANDING ZONE ARTERY SIZE MEASUREMENTS WERE 2.77MM DISTALLY AND 3.38MM PROXIMALLY. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 20F. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A JOHNSON JOHNSON SHEATH, JOHNSON JOHNSON GUIDE CATHETER, AND A SY-2 GUIDEWIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17807562 ↗MalfunctionSep 14, 2023Material Deformation; Activation Failure; Material Deformation; Activation Failure
ADDITIONAL INFORMATION RECEIVED THAT AFTER ANGIOGRAPHY, AFTER PERFORMING 2D CALIBRATION OF THE NAVIEN TIP DIAMETER, THE BLOOD VESSELS WERE MEASURED. THE PROXIMAL DIAMETER OF THE DISTAL ANCHOR POINT M1 WAS 2.5MM, THE DIAMETER OF THE PROXIMAL LANDING POINT ANTERIOR TO THE OPHTHALMIC ARTERY WAS 2.9MM, AND THE LENGTH WAS 18MM. FOR SAFETY REASONS, CHOSE PED-275-20 DENSE MESH STENT FOR IMPLANTATION. THE ACCESS USED 6F-90 LONG SHEATH + 5F115NAVIEN. DELIVERED THE MARKSMAN STENT CATHETER TO THE M2 SEGMENT THROUGH THE GUIDE WIRE, AND WITHDREW THE GUIDE WIRE. UNPACKED THE STENT AND PERFORMED HIGH-PRESSURE INFUSION TO HYDRATE IT UNTIL 10 DROPS OF WATER WERE RELEASED. AFTER PRESSING THE DELIVERY SHEATH AGAINST THE MARKSMAN HUB PORT, DELIVERED THE STENT TO M2 SEGMENT. AFTER THE STENT CATHETER CAME OUT, OPENED THE TIP END OF THE STENT. THE TIP END OF THE STENT WAS OPENED BY ABOUT 6MM. THE OPENING WAS IN GOOD CONDITION. AFTER LOCKING THE Y VALVE, PULLED BACK AND ANCHORED. AFTER ANCHORING, DEPLOYED THE MIDDLE SECTION OF THE STENT UNDER FLUOROSCOPY. WHEN THE STENT WAS DEPLOYED TO THE NECK OPENING OF THE C6 SEGMENT OF THE INTERNAL CAROTID ARTERY, THE ADHESION OF THE STENT TO THE WALL WAS OBSERVED UND
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17748810 ↗DeathAug 23, 2023Unintended Movement; Physical Resistance/Sticking; Unintended Movement; Physical Resistance/Sticking
ADDITIONAL INFORMATION WAS RECEIVED REPORTING NO FRICTION OR RESISTANCE ENCOUNTERED DURING DEPLOYMENT OF THE FIRST PIPELINE. THE PIPELINE DEVICES WERE NOT RESHEATHED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17604370 ↗MalfunctionJul 31, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT THE MICROCATHETER WAS IN PLACE, AND THE PIPELINE WAS DIFFICULT TO PUSH OUT. MANY ATTEMPTS WERE PERFORMED, BUT THE PIPELINE CONTINUED TO EXPERIENCE RESISTANCE IN THE DISTAL SEGMENT OF THE CATHETER. IT WAS STATED THAT IT WAS NOT STUCK, A CONTINUOUS FLUSH WAS USED, AND NO DAMAGE WAS OBSERVED. A NEW STENT WAS SUCCESSFULLY DELIVERED THROUGH THE CATHETER TO COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE OPHTHALMIC ARTERY SEGMENT WITH A MAX DIAMETER OF 8MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17427888 ↗MalfunctionJun 30, 2023Activation Failure; Activation Failure
MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX (PED) THAT FAILED TO OPEN AT THE DISTAL END. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF AN UNRUPTURED C6 SEGMENT SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 4.4MM. THE DISTAL LANDING ZONE WAS 2.75MM AND THE PROXIMAL LANDING ZONE WAS 3.1MM. VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) REGIMEN (ASPIRIN AND CLOPIDOGREL) WAS ADMINISTERED 3 DAYS BEFORE THE PROCEDURE. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS DELIVERED IN PLACE. HOWEVER, DURING DEPLOYMENT, THE DISTAL END OF THE PIPELINE FAILED TO OPEN WHEN MORE THAN 50% OF THE PIPELINE WAS DEPLOYED. IT WAS NOTED THAT THE PIPELINE WAS NOT POSITIONED IN A BEND. THE PIPELINE WAS RESHEATHED 2 OR LESS TIMES; IT WAS UNKNOWN IF ANY ADDITIONAL STEPS OR DEVICES WERE USED TO TRY AND OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT'S BODY WITH THE MICROCATHETER. A NEW DENSE MESH STENT WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. POST-PROCEDURE ANGIOGR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17238383 ↗MalfunctionMay 19, 2023Material Deformation; Activation Failure; Material Deformation; Activation Failure
ADDITIONAL INFORMATION RECEIVED THAT THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN, BUT THE BLOOD VESSEL WAS INDEED RELATIVELY THIN AND DIFFICULT TO OPEN. THERE WERE ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE INCLUDING THERE WAS AN OPERATION TO RECYCLE AND REOPEN THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16969802 ↗MalfunctionApr 5, 2023Activation Failure; Activation Failure
MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR ANEURYSM WITH A MAX DIAMETER OF 29 MM AND A 7-10 MM NECK DIAMETER. THE LANDING ZONE SIZE IS UNKNOWN. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS UNKNOWN. IT IS UNKNOWN IF DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. IT WAS REPORTED THAT PIPELINE WAS PUT IN POSITION AND FAILED TO OPEN UPON DELIVERY. PRODUCT REMOVED AND NEW PIPELINE OPENED AND WORKED FINE. IT WAS REPORTED THE PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. IT IS UNKNOWN IF THE PIPELINE WAS POSITIONED IN A BEND. IT IS UNKNOWN HOW MUCH OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. IT IS UNKNOWN HOW MANY TIMES THE PIPELINE WAS RESHEATHED. IT IS UNKNOWN IF THERE WERE ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS REMOVED FROM THE PATIENT BY RESHEATHING AND REMOVING WITH THE MICROCATHETER. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS OFF-LABEL. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT IS UNKNOWN IF THE PATIENT HAD ANY SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16681600 ↗MalfunctionDec 1, 2022Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking
ADDITIONAL INFORMATION RECEIVED REPORTED AFTER THE PIPELINE WAS OPENED, IT WAS IN THE STRAIGHT SEGMENT OF THE DISTAL M1. NO OTHER STEPS OR DEVICES WERE USED TO OPEN THE PIPELINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15898155 ↗MalfunctionNov 7, 2022Activation Failure; Activation Failure
MEDTRONIC RECEIVED A REPORT THAT AFTER THE STENT MICROCATHETER WAS IN PLACE, THE STENT WAS DELIVERED TO THE PREDETERMINED POSITION. WHEN THE DISTAL END OF THE STENT WAS DEPLOYED, IT WAS FOUND THAT IT COULD NOT BE OPENED, AND REPEATED ADJUSTMENTS WERE INEFFECTIVE. THE DISTAL SECTION WAS POSITIONED IN A BEND. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRE TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED OPHTHALMIC ARTERY SEGMENT ANEURYSM WITH A MAX DIAMETER OF 3.5 MM AND A 4 MM NECK DIAMETER. THE LANDING ZONE WAS 3.2 MM AT THE DISTAL END AND 3.3 MM AT THE PROXIMAL END. IT WAS NOTED THE PATIENT'S BLOOD VESSEL TORTUOSITY WAS MODERATE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS NOT ADMINISTERED. THE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15742973 ↗MalfunctionNov 2, 2022Physical Resistance/Sticking; Physical Resistance/Sticking
MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX THAT HAD RESISTANCE AND WAS STUCK IN THE MARKSMAN MICROCATHETER. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER TREATMENT OF AN UNRUPTURED SACCULAR RIGHT INTERNAL CAROTID ARTERY OPHTHALMIC SEGMENT ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 12MM AND THE NECK DIAMETER WAS 10MM. VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED FOR 7 DAYS PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. AFTER THE MARKSMAN MICROCATHETER WAS POSITIONED IN THE DISTAL MIDDLE CEREBRAL ARTERY (MCA). THE PIPELINE WAS THEN SELECTED. THERE WAS SEVERE RESISTANCE WHEN THE PIPELINE WAS DELIVERED THROUGH THE MARKSMAN AND IT WAS UNABLE TO BE PUSHED OUT. THE DEVICES WERE WITHDRAWN TOGETHER AND IT WAS FOUND THE PIPELINE WAS STUCK WITHIN THE MARKSMAN. THE PROXIMAL END OF THE MARKSMAN WAS NOTED TO HAVE ACCORDION DAMAGE. THE PIPELINE WAS NOT NOTED TO BE DAMAGE. A NEW MARKSMAN MICROCATHETER WAS THEN PLACED IN THE DISTAL MIDDLE CEREBRAL ARTERY AND A PIPELINE FLEX (MODEL:PED-325-25) WAS DELIVERED AND DEPL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15715520 ↗MalfunctionOct 11, 2022Activation Failure; Activation Failure
2022-OCT-07 MPXR 991711 (REP, HCP, FOR): MEDTRONIC RECEIVED INFORMATION THAT A PED PIPELINE DEVICE FAILED TO OPEN IN THE DISTAL SECTION. AFTER THE CATHETER WAS IN PLACE, THE PED-450-35 STENT WAS DEPLOYED. WHEN IT WAS DEPLOYED, IT WAS FOUND THAT THE TIP END OF THE STENT COULD NOT BE OPENED. LATER, REPLACED WITH PED-450-30 STENT, AND IT WAS DEPLOYED NORMALLY. IT BELONGED TO THE NORMAL OPERATIONAND THE PATIENT HAD NO ABNORMALITY. THE DISTAL SECTION OF THE PIPELINE WAS POSITIONED IN A BEND. LESS THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE HAD BEEN RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. NO ADDITIONAL STEPS WERE REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, AMORPHOUS ANEURYSM IN THE CAVERNOUS SINUS SEGMENT.THE MAX DIAMETER WAS 29MM AND THE NECK DIAMETER WAS 14MM. THE DISTAL LANDING ZONE WAS 3.92MM. THE PROXIMAL LANDING ZONE WAS 5.3MM. VESSEL TORTUOSITY WAS SEVERE. THE ANGIOGRAPHY WAS IN GOOD CONDITION POST PROCEDURE. NO PATIENT SYMPTOM OR COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15578036 ↗MalfunctionSep 8, 2022Activation Failure; Activation Failure
ADDITIONAL INFORMATION RECEIVED REPORTED THE PIPELINE WAS NOT POSITIONED IN A BEND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15385799 ↗InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD A PIPELINE FLEX IMPLANTED IN AN ARTERY BEHIND THE PATIENT'S EYE TO ADDRESS AN ANEURYSM. THE CALLER MENTIONED IT TOOK THE PHYSICIAN 8 TRIES TO IMPLANT THE PRODUCT AND THIS CLOSED THE PATIENT'S MAIN ARTERY LEADING TO THEIR BRAIN. THE PHYSICIAN EXPLAINED WHAT HAPPENED TO THE PATIENT 3 DAYS POST IMPLANT, THAT THE ARTERY CLOSED, AND 3 DAYS FOLLOWING THAT A HOSPITAL SPOKESPERSON EXPLAINED THE PATIENT HAD A BLOOD CLOT THEN A STROKE. THE PHYSICIAN LATER SAID NO, THE ARTERY CLOSED. THE PATIENT WAS DISCHARGED AFTER A DELAYED PROCESS TO LEAVE FACILITY AND LONG TRANSPORT TO LONG TERM CARE, LATER THAT NIGHT THE PATIENT HAD A "CODE BLUE" AND SUFFERED A MASSIVE STROKE THEN SPENT 1 MONTH IN A NEURO ICU RECOVERING. THE CALLER'S ORIGINAL QUESTION ABOUT MRI SAFETY WAS DUE TO THE PATIENT HAVING FREQUENT VOMITING OVER THE LAST 2 MONTHS AND LOSING 25 POUNDS OF BODY WEIGHT. THE MRI WAS TO HELP DETERMINE WHAT MIGHT BE CAUSING THE FREQUENT VOMITING.
Patient problems: Nausea; Obstruction/Occlusion; Stroke/CVA; Thromboembolism
MAUDE report 15341081 ↗
Other Micro Therapeutics, Inc. products
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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