Ascenda® 8780 (UDI 00763000916657)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000916657), received between Sep 16, 2024 and Apr 23, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Improper or Incorrect Procedure or Method; Difficult to Advance

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING DILAUDID (8MG/ML AT 0.3847MG/DAY). IT WAS REPORTED THAT DURING A CATHETER REVISION, THE CATHETER WAS GOING TO BE REPLACED WITH A NORMAL CATHETER KIT, BUT THE PHYSICIAN PREMATURELY REMOVED THE STYLET FROM THE SPINAL SEGMENT IN THE KIT AND WAS UNABLE TO REINSERT IT. THEY ATTEMPTED TO PLACE THE CATHETER WITHOUT THE STYLET BUT WAS UNABLE TO. THE PHYSICIAN ASKED FOR A SPINAL SEGMENT KIT WHICH WAS PROVIDED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968303 ↗
• MalfunctionAug 11, 2025Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN IMPLANTED INFUSION PUMP. THE PUMP WAS USED TO DELIVER UNKNOWN MORPHINE 1MG/ML AT A DOSE OF "0.1MG". IT WAS REPORTED THAT, DURING A PROCEDURE, THE CATHETER HAD A BEND "1/4 IN FROM THE TIP" AND WOULD NOT ADVANCE. THE DOCTOR TRIED TO STRAIGHTEN IT OUT AND WAS STILL UNABLE TO ADVANCE PLACEMENT OF THE TIP. THE DOCTOR ALSO PULLED THE GUIDEWIRE OUT BUT ALSO COULD NOT ADVANCE. THIS RESULTED IN OPENING A NEW 8780 CATHETER. IN REGARDS TO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE, "BAD PRODUCT MANUFACTURING" WAS REPORTED. AT THE TIME OF THIS REPORT, THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22771560 ↗
• MalfunctionAug 7, 2025Connection Problem; Connection Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING INTRATHECAL HYDROMORPHONE 25 MG/ML AT 2.796 MG/DAY VIA AN IMPLANTED PUMP FOR AN UNKNOWN INDICATION FOR USE. IT WAS REPORTED THAT THE CONNECTOR BETWEEN THE PUMP AND TIP SEGMENT OF THE CATHETER WOULD NOT LOCK IN PLACE. NO PATIENT SYMPTOMS OR DISRUPTION IN THERAPY DUE TO THIS ISSUE. THE CATHETER WAS NEVER IMPLANTED AND WOULD BE RETURNED. IT WAS NOTED THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO SECURE THE CATHETER PIECES TOGETHER. ULTIMATELY THE PHYSICIAN DID NOT FEEL AS IF IT WOULD LOCK IN PLACE, AND REQUESTED A CATHETER FROM A DIFFERENT LOT BE USED. A DIFFERENT CATHETER WAS USED TO COMPLETE THE CASE WITHOUT INCIDENT. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. THE CAUSE WAS COMPLETED WITHOUT INJURY TO THE PATIENT. ONCE THE PHYSICIAN DETERMINED THE CATHETER REFERRED TO IN THIS REPORT TO BE INADEQUATE, A DIFFERENT CATHETER WAS USED WITH NO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22743207 ↗
• InjuryJul 23, 2025Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING CATHETERS FOR AN IMPLANTABLE INTRATHECAL PUMP. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO THREAD THE CATHETER CEPHALAD; THEY KEPT WANTED TO GO DOWN INSTEAD OF UP. AN EXTERNAL FACTOR WAS THAT THE PHYSICIAN WAS ENTERING THE INTRATHECAL SPACE WITHOUT THE USE OF LIVE FLUOROSCOPY AT A 90 DEGREE ANGLE. THE PHYSICIAN USED SPOT CHECKS INTERMITTENTLY INSTEAD OF LIVE FLUOROSCOPY. THE PHYSICIAN SHEARED THE CATHETER. A SPINAL SEGMENT WAS GIVEN TO THE PHYSICIAN AND THE PHYSICIAN SHEARED THE SPINAL SEGMENT, AS WELL AS THE NEXT TWO SPINAL SEGMENTS GIVEN TO THEM. THE PHYSICIAN COMPLAINED THAT THE NEEDLE WAS "CRAPPY" AND BECAME BLUNT/BENT UPON ENTRY AND ASKED FOR A NEW NEEDLE. THE MANUFACTURER REPRESENTATIVE GAVE THE PHYSICIAN THEIR LAST CATHETER AND THE SAME ISSUE RECURRED WITH THE INABILITY TO THREAD THE CATHETER CEPHALAD INSTEAD OF DOWN, AND THE LAST CATHETER WAS SHEARED. THE CASE WAS ABORTED DUE TO THE INABILITY TO PROPERLY PLACE THE CATHETER AND RESCHEDULED FOR (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22583342 ↗
• InjuryJul 23, 2025Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING CATHETERS FOR AN IMPLANTABLE INTRATHECAL PUMP. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO THREAD THE CATHETER CEPHALAD; THEY KEPT WANTED TO GO DOWN INSTEAD OF UP. AN EXTERNAL FACTOR WAS THAT THE PHYSICIAN WAS ENTERING THE INTRATHECAL SPACE WITHOUT THE USE OF LIVE FLUOROSCOPY AT A 90 DEGREE ANGLE. THE PHYSICIAN USED SPOT CHECKS INTERMITTENTLY INSTEAD OF LIVE FLUOROSCOPY. THE PHYSICIAN SHEARED THE CATHETER. A SPINAL SEGMENT WAS GIVEN TO THE PHYSICIAN AND THE PHYSICIAN SHEARED THE SPINAL SEGMENT, AS WELL AS THE NEXT TWO SPINAL SEGMENTS GIVEN TO THEM. THE PHYSICIAN COMPLAINED THAT THE NEEDLE WAS "CRAPPY" AND BECAME BLUNT/BENT UPON ENTRY AND ASKED FOR A NEW NEEDLE. THE MANUFACTURER REPRESENTATIVE GAVE THE PHYSICIAN THEIR LAST CATHETER AND THE SAME ISSUE RECURRED WITH THE INABILITY TO THREAD THE CATHETER CEPHALAD INSTEAD OF DOWN, AND THE LAST CATHETER WAS SHEARED. THE CASE WAS ABORTED DUE TO THE INABILITY TO PROPERLY PLACE THE CATHETER AND RESCHEDULED FOR (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22583313 ↗
• MalfunctionMar 31, 2025Separation Failure; Separation Failure

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING TWO CATHETERS. IT WAS REPORTED THAT THE STYLETS WOULD NOT COME OUT OF THE CATHETERS. ANOTHER CATHETER WAS USED AND THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733937 ↗
• MalfunctionMar 31, 2025Separation Failure; Separation Failure

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING TWO CATHETERS. IT WAS REPORTED THAT THE STYLETS WOULD NOT COME OUT OF THE CATHETERS. ANOTHER CATHETER WAS USED AND THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733932 ↗
• MalfunctionFeb 12, 2025Obstruction of Flow; Obstruction of Flow

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A COMPANY REPRESENTATIVE (REP) REGARDING AN OUT OF BOX CATHETER. IT WAS REPORTED THAT THE CATHETER HAD BEEN OPENED AND NOT USED DUE TO A KINK OR BEND IN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21366717 ↗
• MalfunctionJan 2, 2025Obstruction of Flow; Obstruction of Flow

  ON 2024-DEC-23 (B)(4) AND UPDATE (HCP, REP): INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING INTRATHECAL 500MCG/ML AT 50 MCG WITH AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE SPINAL PORTION OF THE CATHETER WAS KINKED WHEN OPENED FOR THE FIRST TIME. THERE WERE NO FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE AND NO DIAGNOSTICS/TROUBLESHOOTING WAS PERFORMED. ACTIONS/INTERVENTIONS TAKEN INCLUDED THE PHYSICIAN ASKING TO OPEN A NEW CATHETER TO IMPLANT. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21055959 ↗
• MalfunctionSep 16, 2024Obstruction of Flow; Obstruction of Flow

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING AN 8780 CATHETER. IT WAS UNKNOWN IF THERE WAS ANY ENVIRONMENTAL/ EXTERNAL/ PATIENT FACTORS THAT HAD LED OR CONTRIBUTED TO THE EVENT. DIAGNOSTICS/ TROUBLESHOOTING PERFORMED INCLUDED THAT WHEN THE SURGEON WENT TO PLACE THE CATHETER, IT HAD A BEND IN IT. THE HCP TRIED TO STRAIGHTEN IT BUT IT WAS A PERMANENT KINK. THE ISSUE WAS NOT RESOLVED AND THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224667 ↗

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-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
• 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

…and 25 more.