Ascenda™ 8780Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169202122), received between Dec 6, 2016 and Jun 28, 2022 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

39 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.

Recalls naming this device

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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2022Infusion or Flow Problem; Material Integrity Problem; Infusion or Flow Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING MORPHINE (0.5 MG/ML, DOSE 0.025 MG/DAY) VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PUMP HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) PRIOR TO THE ESTIMATED ERI DATE. PRIOR TO BEING TAKEN TO THE OPERATION ROOM (OR), THE PHYSICIAN PERFORMED A CATHETER ACCESS STUDY AND WAS UNABLE TO ASPIRATE CEREBROSPINAL FLUID FLOW CSF FROM THE PORT. THE PATIENT WAS SUBSEQUENTLY TAKEN TO THE OR AND PLACED IN A LATERAL POSITION. THE PHYSICIAN STARTED BY OPENING THE PUMP POCKET AND DISSECTING OUT THE PUMP AND PROXIMAL SEGMENT. ONCE THE PUMP WAS DISSECTED OUT, HE AGAIN ATTEMPTED TO ASPIRATE FROM THE CATHETER ACCESS PORT BUT WAS AGAIN UNSUCCESSFUL. THE PUMP WAS DISCONNECTED AND DISCARDED FOR PLANNED REPLACEMENT. THE PROXIMAL PUMP SEGMENT WAS DISCONNECTED FROM THE SPINAL SEGMENT AT THE COLLET. THE PHYSICIAN THEN PROCEEDED WITH ANOTHER ATTEMPT TO ASPIRATE DIRECTLY FROM THE CATHETER, WHICH WAS AGAIN UNSUCCESSFUL. THE PHYSICIAN THEN PROCEEDED TO OPEN THE LUMBAR INCISION. HE DISSECTED DOWN TO THE CATHETER ANCHOR AND SPLICED THE CATHETER BELOW THE ANCHOR SITE. THERE WAS STILL NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14848580 ↗
• InjuryAug 21, 2020Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem

  (B)(6) 2020 (B)(4) (HCP, REP): INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA COMPANY REP REGARDING A PATIENT RECEIVING DILAUDID (1MG/ML AT .1MG/DAY) VIA INTRATHECAL INFUSION PUMP FOR AN UNKNOWN INTENDED USE.

  Patient problems: No Known Impact Or Consequence To Patient; Pain

  MAUDE report 10439150 ↗
• InjuryAug 5, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA COMPANY REP REGARDING A PATIENT RECEIVING FENTANYL (700MCG/ML AT 560MCG/DAY), HYDROMORPHONE (4MG/ML AT 3.2MG/DAY), AND BUPIVACAINE (11MG/ML AT 8.8MG/DAY) VIA INTRATHECAL INFUSION PUMP FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPY, SO THEY WENT IN FOR REVISION. IT WAS NOT KNOWN WHEN THE LOSS OF THERAPY STARTED. A DYE STUDY WAS PERFORMED AND THERE WAS NO FREE FLOW OF CSF. IT WAS STATED THAT WHEN THE CATHETER WAS REMOVED CRYSTALLIZATION WAS FOUND AT THE TOP OF THE CATHETER. THE ENTIRE CATHETER WAS REPLACED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 10369216 ↗
• MalfunctionNov 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A CATHETER USED WITH AN IMPLANTED INFUSION SYSTEM. NO PATIENT INVOLVEMENT WAS REPORTED. IT WAS REPORTED THAT PRIOR TO OPENING THE CATHETER PEEL PACK, THE REPRESENTATIVE NOTICED THE SLEEVE OF THE COLLET WAS MISSING FROM THAT CONNECTOR. THE REPRESENTATIVE LOCATED IT BROKEN OFF IN THE PEEL PACK. NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS WERE THOUGHT TO HAVE LED OR CONTRIBUTED TO THE ISSUE. THE REPRESENTATIVE OPENED AND USED A NEW CATHETER ISSUE, AND THE ISSUE WAS NOT RESOLVED. AN IMAGE SUBMITTED WITH THE REPORT SHOWED THE COLLET SLEEVE SEPARATED FROM THE CATHETER CONNECTOR. NO PATIENT SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8074460 ↗
• MalfunctionDec 8, 2017Activation, Positioning or Separation Problem; Device Operates Differently Than Expected; Activation, Positioning or Separation Problem; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT RECEIVING DILAUDID (HYDROMORPHONE) 2MG/ML FOR A TOTAL DOSE OF 0.1MG/DAY VIA AN IMPLANTABLE PUMP FOR SPINAL PAIN. IT WAS REPORTED THAT THE ANCHOR DEPLOYMENT TOOL BROKE WHEN TRYING TO DEPLOY THE ANCHOR. IT WAS NOTED THAT THE PATIENT WAS LARGE, AND THE ANGLE WAS STEEP. IT WAS NOTED THAT T HE DEVICE (ANCHOR TOOL) AND THE ANCHOR WERE REMOVED. A NEW ANCHOR WAS USED. THE ISSUE WAS RESOLVED AT TIME OF REPORT. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7102319 ↗
• MalfunctionMar 24, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA A COMPANY REPRESENTATIVE REGARDING A CATHETER REPLACEMENT EVENT THAT OCCURRED INTRA-OPERATIVELY ON THIS REPORT DATE, THERE WAS AN OUT OF BOX FAILURE AT IMPLANT. IT WAS REPORTED THAT, INTRAOPERATIVELY, UPON DEPLOYMENT OF THE ANCHOR, THE DISTAL END OF THE ANCHOR FOLDED OVER ITSELF AND MADE THE CATHETER ¿UN-USABLE¿. A DIFFERENT CATHETER SEGMENT WAS USED WITH NO ISSUE. THE CATHETER WAS TO BE RETURNED TO THE MANUFACTURER. IT WAS NOTED THAT AT THE TIME OF THE EVENT THE PUMP HAD NOT YET BEEN IMPLANTED, THE PUMP SERIAL NUMBER WAS UNKNOWN. THERE WAS NO PATIENT THERAPY ISSUE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6431140 ↗
• InjuryFeb 18, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE DRUG INFUSION PUMP INDICATED FOR NON-MALIGNANT PAIN. THE PUMP CONTAINED FENTANYL WITH A CONCENTRATION OF 50 MCG/ML AT A DOSE OF 25 MCG/DAY. IT WAS REPORTED THE PATIENT STARTED EXPERIENCING SEVERE PAIN AFTER SURGERY. THE HCP OPENED THE BACK INCISION AND PULLED DOWN THE CATHETER. WHEN THE PATIENT AWOKE FROM SURGERY, SHE STATED HER PAIN WAS CONSIDERABLY BETTER. IT WAS UNKNOWN WHAT ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MIGHT HAVE LED OR CONTRIBUTED TO THE ISSUE. IT WAS UNKNOWN WHAT DIAGNOSTICS/TROUBLESHOOTING WAS PERFORMED. THE ONLY INTERVENTION WAS CATHETER REVISION. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION RECEIVED FROM THE REPRESENTATIVE ON 2017-FEB-16 REPORTED A NURSE PRACTITIONER TOLD THEM WHAT WAS GOING ON WHEN THEY SHOWED UP TO COVER THE CASE. THE DOCTOR THOUGHT THE CATHETER MIGHT HAVE BEEN BUMPING A NERVE. THE REPRESENTATIVE HAD NOT HEARD ANYTHING ELSE REGARDING THE PATIENT. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE ¿ NO INJURY.

  Patient problems: Pain

  MAUDE report 6342373 ↗
• MalfunctionDec 6, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER¿S REPRESENTATIVE REGARDING A PATIENT¿S IMPLANTABLE INFUSION PUMP SYSTEM. IT WAS REPORTED ON (B)(6) 2016 THAT DURING A PROCEDURE THE ANCHOR TOOL WOULD NOT ALLOW FOR DEPLOYMENT. IT WAS REPORTED THAT THE T PORTION OF THE INJEX SYSTEM DID NOT WORK AND TROUBLESHOOTING WAS ATTEMPTED; THE HEALTHCARE PROVIDER TRIED TO REALIGN THE T PIECE, BUT WAS UNABLE TO GET DEPLOYMENT TO OCCUR. A SECOND CATHETER KIT HAD TO BE OPENED TO OBTAIN AN ANCHOR. THE ISSUE WAS RESOLVED AT THE TIME THIS EVENT WAS REPORTED. THE PATIENT WAS BEING MEDICATED THROUGH THE PUMP WITH MORPHINE AT A CONCENTRATION OF 5MG/ML, AND A DOSE OF 0.9MG/DAY. THE PATIENT¿S MEDICAL HISTORY WAS UNKNOWN. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6148320 ↗

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-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-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
• 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-2276-2009 · Jul 1, 2009 · Terminated
  Medtronic SynchroMed II Programmable Pump, 8637, Rx Only, Sterilized by ethylene oxide gas, Medtronic inc., Minneapolis, MN 55432-5604. (The SynchroMed II Pump is supplied in 20 m

…and 24 more.