Ascenda 8780Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00613994555595), received between Mar 23, 2016 and Jun 8, 2026 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (4 reports).

40 other recalls cover devices cleared under the same FDA submission (P860004); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryJun 8, 2026Obstruction of Flow; Failure to Disconnect; Infusion or Flow Problem; Material Integrity Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIV ING FENTANYL (1500 MCG/DAY AT 271.7 MCG/DAY) VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT A CATHETER ACCESS STUDY WAS DONE IN (B)(6) 2026 IN PREPARATION FOR PROPHYLACTIC PUMP REPLACEMENT DUE TO EOS. UNFORTUNATELY, HE WAS UNABLE TO ASPIRATE ANY CSF FROM THE CATHETER ACCESS PORT AND THE PATIENT WAS SUBSEQUENTLY SCHEDULED FOR CATHETER REVISION WITH ROUTINE PUMP REPLACEMENT. THE CATHETER WAS FOUND TO BE ANCHORED TO SUBCUTANEOUS FAT AND NOT THE FASCIA. THE HEALTHCARE PROVIDER ALSO REPORTED CALCIUM BUILDUP WITHIN THE PUMP POCKET. EXACT CAUSE OF CATHETER OBSTRUCTION WAS UNKNOWN. DURING SURGERY THE PHYSICIAN DISSECTED OUT THE FULL LENGTH OF THE PROXIMAL SEGMENT BUT DID NOT NOTE ANY CSF FROM THE CATHETER. HE THEN PROCEEDED TO DISCONNECT THE PROXIMAL SEGMENT FROM THE SPINAL SEGMENT AT THE COLLET. HE ATTEMPTED TO ASPIRATE DIRECTLY FROM THE SPINAL SEGMENT, BUT HAD NO RETURN OF FLUID. HE THEN PROCEEDED TO FLUSH PRESERVATIVE FREE NORMAL SALINE THROUGH THE CATHETER MULTIPLE TIMES, CAUTIONED ABOUT DRUG REMAINING IN CATHETER, BUT STILL HAD NO RETURN OF CSF. HE THEN P

  Patient problems: Calcium Deposits/Calcification; Insufficient Information

  MAUDE report 25432285 ↗
• InjurySep 2, 2021Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CATHETER PLACEMENT HAS NOT BEEN SCHEDULED YET SO THE ISSUE REMAINS UNRESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12415163 ↗
• InjuryJan 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER VIA A CLINICAL STUDY REPORTED THE PATIENT WAS RECEIVING BACLOFEN (2000 MCG AT 599.57712 MCG/DAY) VIA AN IMPLANTED PUMP.

  Patient problems: Cerebrospinal Fluid Leakage; Nausea; Vomiting

  MAUDE report 11204572 ↗
• InjuryNov 24, 2020Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP WHO REPORTED THAT THE CAUSE OF THE INABILITY TO ASPIRATE AND KINK WERE UNKNOWN AND THEY WOULD BE RETURNING THE DEVICE TODAY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 10892229 ↗
• InjuryOct 16, 2020Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS RECEIVING MORPHINE VIA IMPLANTABLE PUMP. IT WAS REPORTED THAT EARLIER THIS WEEK THE PATIENT PRESENTED WITH WITHDRAWAL SYMPTOMS. A CATHETER STUDY WAS PERFORMED BUT THEY WERE UNABLE TO ASPIRATE THE CATHETER. THERE WERE NO KNOWN EXTERNAL FACTORS. A CATHETER REVISION WAS SCHEDULED TO TAKE PLACE ON (B)(6) 2020.

  Patient problems: Dehydration; Diarrhea; Insufficient Information; Therapeutic Response, Decreased; Vomiting

  MAUDE report 10692246 ↗
• MalfunctionFeb 13, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2020, INFORMATION WAS RECEIVED FROM AN HEALTHCARE PROFESSIONAL (HCP), VIA A MANUFACTURER REPRESENTATIVE (REP), REGARDING A PATIENT RECEIVING DILAUDID (20 MG/ML, 4.5 MG/DAY) VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN AND CHRONIC LOW BACK PAIN. THE PATIENT HAD THEIR PUMP REPLACED ON THE DATE OF THIS REPORT FOR A ROUTINE PUMP REPLACEMENT DUE TO THE PUMP REACHING ESTIMATED REPLACEMENT INDICATOR (ERI). AFTER DISCONNECTING THE SUTURE-LESS CONNECTOR OF THE 8780, THE HCP SAW SOME TISSUE IN THE CAP AND CHOSE TO REPLACE THE PUMP SEGMENT. THERE WERE NO KNOWN EXTERNAL FACTORS AND NO DIAGNOSTICS WERE PERFORMED. THE PUMP SEGMENT WAS REPLACED WITH A 8784 REVISION KIT. THE SPINAL SEGMENT OF THE 8780 REMAINED IN PLACE AND STILL IN USE. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9707346 ↗
• MalfunctionFeb 3, 2020Material Integrity Problem; Material Integrity Problem

  ON (B)(6) 2020, INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) THROUGH AN UPDATE TO DEVICE REGISTRATION. IT REPORTED THE CATHETER 8780 ((B)(4)) WAS NOT USED DUE TO GETTING BENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9660583 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING UNKNOWN DRUG VIA AN IMPLANTED PUMP. THE INDICATION FOR USE WAS SPINAL PAIN. IT WAS REPORTED THE PATIENT'S PUMP AND CATHETER WERE ELECTIVELY REPLACED ON (B)(6) 2019 AND PART OF THE CATHETER WAS LEFT IN THE PATIENT'S BODY. A HEMATOMA DEVELOPED DUE TO THE REMOVAL AND THE PATIENT HAD TO GO TO THE TRAUMA CENTER AT THE HOSPITAL WHERE THEY DID TESTS AND BLOOD WORK. THE BLOOD WORK SHOWED NO INFECTION AND THE PATIENT WAS REFERRED BACK TO PHYSICIAN THAT REMOVED THE DEVICE. THE PATIENT LAID DOWN AND WOKE UP SUNDAY MORNING WET AND WAS BLEEDING EVERYWHERE AS THE HEMATOMA HAD OPENED UP. THE PATIENT PUT SOME GAUZE ON THE HEMATOMA AND WENT TO THE HOSPITAL WHERE THEY SAY FOR 3-4 HOURS. THE PATIENT THEN WENT TO THE DIFFERENT HOSPITAL WHERE THE PHYSICIAN PUT A NEW PATCH ON THE HEMATOMA EVERY DAY AND SAID IT WOULD TAKE MONTHS TO RESOLVE. THE PATIENT THEN WENT TO CALIFORNIA AND WENT TO THE EMERGENCY ROOM BECAUSE THEY WERE FEELING FUNNY AND HAD AN ULTRASOUND DONE. THE TECH SAID THERE IS A PART THE IS NOT GOING TO DISSOLVE AND NO GENERAL SURGEON WOULD REMOVE IT. THE PATIENT THEN WENT TO MEXICO TO VISIT THEIR WIFE'S FAMILY AND LAID DOW

  Patient problems: Complaint, Ill-Defined; Hematoma; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection

  MAUDE report 9008937 ↗
• MalfunctionJun 21, 2019Obstruction of Flow; Obstruction of Flow

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA PRODUCT SURVEILLANCE REGISTRY (PSR) REGARDING A PATIENT RECEIVING INTRATHECAL MORPHINE (CONCENTRATION 5MG/ML; DOSE 0.2403MG/DAY; LOT UNKNOWN) VIA AN IMPLANTABLE INFUSION PUMP. INDICATION FOR USE WAS NON-MALIGNANT PAIN. THE PATIENT EXPERIENCED DECREASED PAIN RELIEF DUE TO ¿SLUGGISH CATHETER¿ AND CATHETER OCCLUSION. THE PATIENT INDICATED THAT HE HAD BEEN GETTING SIGNIFICANT PAIN RELIEF UNTIL RECENTLY AND NOW THE PUMP WAS NOT WORKING AS WELL AS IT HAD BEEN. THE MOST RECENT PUMP REFILL PRIOR TO THE EVENT WAS ON (B)(6) 2014. THE DECREASED PAIN RELIEF WAS DIAGNOSED ON (B)(6) 2014 AT WHICH TIME THE DOSE WAS INCREASED 20% TO 0.2886MG/DAY. PER THE HCP, A CATHETER FLUSH ON (B)(6) 2014 CLEARED A PARTIAL OCCLUSION. ON (B)(6) 2014 A CATHETER ACCESS PORT (CAP) CONTRAST STUDY WAS PERFORMED WHICH REVEALED THE CATHETER WAS SLUGGISH BUT PATENT. PER THE HCP, THIS WAS EQUIVALENT TO THE PATIENT OCCLUSION. THE CATHETER WAS FLUSHED DURING PUMP CHECK ON (B)(6) 2014. THE PUMP DOSE WAS INCREASED ON (B)(6) 2014, AND (B)(6) 2015. DOSE INFORMATION FOR THESE INCREASES WAS NOT PROVIDED. THE EVENT WAS CONSIDERED POSSIBLY RELATED TO THE DEVICE OR THERAP

  Patient problems: Pain; Therapeutic Response, Decreased

  MAUDE report 8722233 ↗
• MalfunctionSep 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MANUFACTURER REPRESENTATIVE RETURNED THE INTRATHECAL CATHETER TO THE MANUFACTURER WITHOUT A COMPLAINT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7903016 ↗
• InjuryMar 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING AN UNKNOWN DRUG AT AN UNKNOWN DOSE AND CONCENTRATION VIA INTRATHECAL DRUG DELIVERY PUMP. THE INDICATION FOR USE WAS NOT NOTED. IT WAS REPORTED THAT A CATHETER REVISION TOOK PLACE. NO SYMPTOMS WERE REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7331839 ↗
• InjuryMar 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURE'S REPRESENTATIVE REGARDING A PATIENT RECEIVING MORPHINE AT A CONCENTRATION OF 15.0 MG/ML AND A DOSE OF 4.817 MG/DAY VIA AN IMPLANTED PUMP. THE INDICATION FOR USE WAS SPINAL PAIN. IT WAS REPORTED THE PATIENT HAD THEIR WHOLE PUMP SYSTEM EXPLANTED ON (B)(6) 2017 AND THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH SPINAL HEADACHE AND CSF LEAK ON (B)(6) 2017. IT WAS INDICATED THE EVENT WAS RELATED TO THE IMPLANT PROCEDURE. IT WAS NOTED THAT ON (B)(6) 2017 SURGICAL REPAIR OF THE CSF LEAK WAS PERFORMED. THE EVENT RESULTED IN THE PATIENT BEING HOSPITALIZED AND PROLONGED HOSPITALIZATION. THE EVENT WAS ONGOING AT THE TIME OF THE EVENT. NO FURTHER COMPLICATIONS ANTICIPATED.

  Patient problems: Cerebrospinal Fluid Leakage; Headache, Lumbar Puncture

  MAUDE report 6402308 ↗
• InjuryFeb 6, 2017Occlusion Within Device; Aspiration Issue; Device Operates Differently Than Expected; Occlusion Within Device; Aspiration Issue; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. IT WAS NOTED THAT THE DOSE OF THE DILAUDID WAS ¿6.5¿ WITH UNITS UNKNOWN. IT WAS REPORTED ON (B)(6) 2017 THAT THE PATIENT HAD A PUMP WHERE THE LINE HAD BECOME BLOCKED. IT WAS NOTED THAT FOR ABOUT SIX MONTHS THE PATIENT EXPERIENCED TROUBLE WITH SIGNIFICANT AMOUNT OF PAIN UNTIL THE POINT OF IT BEING UNBEARABLE AND THEN THEY DECIDED TO REPLACE THE CATHETER ON (B)(6) 2017 (NOTE THE VERBATIM "REPLACE" IS CONFLICTING WITH THE PREVIOUS REPORT THAT A PARTIAL EXPLANT OF THE PUMP SEGMENT OF THE CATHETER WAS REVISED). IT WAS INDICATED THAT THE PATIENT HAD HAD NO RELIEF SINCE IT WAS REPLACED AND THAT SHE WAS EXPERIENCING ZERO RESULTS SO THE PATIENT HAD TO ASSUME THERE WAS A DIFFICULTY OR MALFUNCTION ¿SOMEWHERE.¿ THE PATIENT HAD BEEN GETTING INCREASES IN THE DOSAGE BUT IT DIDN¿T MAKE A DIFFERENCE AND THE PATIENT WASN¿T FEELING THE EFFECTS OF THE BOLUSES EVEN THOUGH THE PERSONAL THERAPY MANAGER (PTM) SAID SHE GOT THE BOLUS. IT WAS ALSO REPORTED THAT THE PUMP WAS GIVING THE PATIENT SIGNIFICANT PAIN IN THE PUMP POCKET. IT WAS STATED THAT THE PATIENT WAS BECOMING SKEPTICAL ABOUT THE PUMP BEING ABLE TO PERFORM AT THIS POINT, PER THE CONSUMER. IT WA

  Patient problems: Pain; Therapeutic Effects, Unexpected; Therapeutic Response, Decreased

  MAUDE report 6305589 ↗
• MalfunctionMar 24, 2016Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS REPORTED BY THE CONSUMER ON 2016-05-09. THE PATIENT REPORTED THAT THEY FIRST STARTED EXPERIENCING THE CATHETER MOVING IN (B)(6) 2015 AFTER THE PUMP HAD BEEN REMOVED AND THE SWELLING WAS DOWN. IT WAS REPORTED THAT THE PATIENT'S PRIMARY CARE PHYSICIAN CALLED THEIR PUMP PHYSICIAN TO CONFIRM THAT IT WAS NOT AN ACCIDENT THAT THE CATHETER WAS LEFT AND WHAT EXACTLY HAD BEEN LEFT IMPLANTED. IT WAS NOTED THAT IT WAS JUST THE CATHETER IN THE POCKET THAT MOVES, NOT THE INTRATHECAL CATHETER.

  Patient problems: Complaint, Ill-Defined; Discomfort; Insufficient Information; No Known Impact Or Consequence To Patient; Scar Tissue; Swelling/ Edema

  MAUDE report 5524163 ↗
• InjuryMar 23, 2016Volume Accuracy Problem; Insufficient Flow or Under Infusion; Material Integrity Problem; Volume Accuracy Problem; Insufficient Flow or Under Infusion; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO RECEIVED UNKNOWN MORPHINE (20MG/ML, 6.9887MG/DAY) AND BUPIVACAINE (20MG/ML, 6.9887MG/DAY) IN AN IMPLANTABLE PUMP FOR CHRONIC LOW BACK PAIN AND SPINAL PAIN. A POCKET REVISION OCCURRED ON (B)(6) 2016 DUE TO A FLIPPED PUMP. X-RAYS WERE REPORTEDLY PERFORMED AT A PREVIOUS DATE, RESULTS WERE NOT REPORTED. THE ISSUE OCCURRED FOR A FEW MONTHS WHERE THE PATIENT COULD MANUALLY FLIP THE PUMP. THE CAUSE OF THE PUMP MOVEMENT WAS UNKNOWN. THE PATIENT EXPERIENCED A BRUISED ABDOMEN AROUND THE PUMP. WHEN THE PUMP SEGMENT "CAME APART" AND A FORCEPS WAS NEEDED TO DISCONNECT FROM THE PUMP. THE PUMP SEGMENT WAS ALSO "PRETTY COILED UP" AND WAS REPLACED WITH A PROXIMAL REVISION KIT. A MESH POUCH WAS ALSO ADDED. THE EXISTING DISTAL CATHETER SEGMENT WAS EASILY ASPIRATED AND REMAINED. THE PUMP WAS RESERVOIR WAS ASPIRATED AND THE ACTUAL RESIDUAL VOLUME WAS 40ML, EXPECTED RESIDUAL VOLUME WAS 19.7ML. THE ISSUE WAS CONSIDERED RESOLVED AT THE TIME OF REPORT. THE DAILY DOSE WAS DECREASED TO 0.960MG/DAY. THE PATIENT'S STATUS AT THE TIME OF THE EVENT WAS STATED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5520368 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P860004. One submission often covers many models, so check the product and lot details in each record.

• Z-2201-2026 · Apr 8, 2026 · Open, Classified
  Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900
• Z-1506-2025 · Jan 9, 2025 · Open, Classified
  A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
• Z-2352-2024 · May 10, 2024 · Open, Classified
  Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
• Z-0614-2024 · Nov 13, 2023 · Open, Classified
  Medtronic SynchroMed II, Model 8637-20, Programmable pump
• Z-0615-2024 · Nov 13, 2023 · Open, Classified
  Medtronic SynchroMed II, Model 8637-40, Programmable pump
• Z-0522-2024 · Jul 13, 2020 · Completed
  Medtronic SynchroMed, Model A10
• Z-0508-2020 · Oct 11, 2019 · Terminated
  Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
• Z-0537-2018 · Sep 21, 2017 · Terminated
  Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UDI: 00643169202153 The Ascenda Intrath
• Z-0896-2018 · Aug 9, 2017 · Open, Classified
  Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed II programmable pump is part of a
• Z-0788-2017 · Oct 3, 2016 · Terminated
  Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 Sy
• Z-1271-2016 · Feb 9, 2016 · Terminated
  Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
• Z-1681-2015 · Apr 10, 2015 · Terminated
  Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an
• Z-1062-2011 · Jan 14, 2011 · Terminated
  Medtronic SynchroMed EL (Model No: 8626 and 8627) implantable drug pump The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion
• Z-1060-2011 · Jan 14, 2011 · Terminated
  Medtronic SynchroMed II (Model No: 8637) implantable drug pump The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the follow
• Z-1061-2011 · Jan 14, 2011 · Terminated
  Medtronic SynchroMed implantable drug pump Refill Kits (Model No: 8551, 8555, 8561, 8562, 8564, 8565, 8566 The Model 8551, 8555, 8561, 8562, 8564, 8565, and 8566 Refill Kits ar

…and 25 more.