AscendaRecalls & reported problems across all models

We found 19 models of Ascenda by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 116 adverse event reports in the FDA's MAUDE database, received between Mar 23, 2016 and Sep 28, 2026 — classified as 30 injuries, 86 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (29 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

Ascenda 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.

1. May 10, 2024Open, Classified

   Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion.

   Z-2352-2024 · Root cause: Device Design · names 9 of these models · Recall details · FDA record ↗

Most reported Ascenda problems

Ascenda models

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

• ASCENDA® 8780

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall33 reports
• ASCENDA® 8781

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall14 reports
• Ascenda™ 8780

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall8 reports
• Ascenda™ 8781

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall7 reports
• Ascenda® 8780

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall7 reports
• ASCENDA® 8784

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall3 reports
• Ascenda® 8781

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall2 reports
• Ascenda® 8784

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall2 reports
• Ascenda™ 8784

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall0 reports
• Ascenda 8780

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  15 reports
• Ascenda® 8780

  Pump, infusion, implanted, programmable
  10 reports
• Ascenda® 8784

  Pump, infusion, implanted, programmable
  4 reports
• Ascenda® 8782

  Pump, infusion, implanted, programmable
  3 reports
• Ascenda 8781

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  2 reports
• ASCENDA® 8785

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  2 reports
• Ascenda™ 8782

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 report
• Ascenda® 8785

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 report
• ASCENDA® 8782

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 report
• Ascenda® 8781

  Pump, infusion, implanted, programmable
  1 report

Recent Ascenda adverse event reports

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

• MalfunctionSep 28, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924257 ↗
• MalfunctionAug 14, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260237 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 16, 2026Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A FOREIGN HEALTH CARE PROVIDER (FOR, HCP) VIA A DISTRIBUTOR (DIS) REGARDING A PATIENT RECEIVING AN UNKNOWN DRUG OF AN UNKNOWN CONCENTRATION AT AN UNKNOWN DOSE RATE VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT WHEN OPENING THE CATHETER PACKAGE, AND INSERTING THE CATHETER INTO THE CATHETER CONNECTOR, IT WAS NOTICED UPON CLOSE INSPECTION THAT THE CONNECTOR WAS DEFORMED. THE METAL PART INSIDE THE CATHETER CONNECTOR WAS BENT. NO PATIENT HARM / INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24612931 ↗
• MalfunctionDec 4, 2025Connection Problem; Connection Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA COMPANY REPRESENTATIVE REGARDING AN IMPLANTABLE CATHETER. IT WAS REPORTED THAT THE COLLET CLAMPED BEFORE IMPLANTING. IT SEEMED TO OCCUR WITH MUCH FORCE THAN USUALLY REQUIRED. THE PRODUCT WAS NEVER IMPLANTED. IT WAS OPENED BUT NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720634 ↗
• MalfunctionOct 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIV ING MORPHINE (4MG/ML AT 0.25 MG/DAY) VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE COLLET IN KIT WAS NON FUNCTIONING AS THE PLASTIC BROKE TO THE DISTAL TIP. THEY OPENED THE PRODUCT ON THE FIELD AND THERE WERE NO ISSUES BEFORE OPENING THE PACKAGING. THEY WERE UNABLE TO TROUBLESHOOT AS THE PRODUCT WAS NOT FUNCTIONING. THEY OPENED A NEW 8785 FOR AN ADDITIONAL COLLET TO COMPLETE THE CASE. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324985 ↗
• 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 ↗
• InjuryAug 5, 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 22717627 ↗
• 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 22583416 ↗
• 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 22583414 ↗
• 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 ↗

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