Ascenda 8781Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994555601), received between Nov 9, 2016 and May 16, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Aspiration Issue” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2018Fluid/Blood Leak; Kinked; Aspiration Issue; Fluid/Blood Leak; Kinked; Aspiration Issue

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A CLINICAL STUDY REGARDING A PATIENT RECEIVING HYDROMORPHONE (10.0 MG/ML AT 2.0 MG/DAY), FENTANYL (1515.0 MCG/ML AT 310.0 MCG/DAY), AND BUPIVACAINE (9 MG/ML AT 1.8 MG/DAY) VIA AN IMPLANTED PUMP. THE INDICATION FOR USE WAS SPINAL PAIN. IT WAS REPORTED THE PATIENT'S PAIN WAS MORE INTENSE COMPARED TO THE PAIN THEY HAD PREVIOUSLY HAD. IT WAS NOTED THE CHANGE WAS DUE TO A FALL. NO ENVIRONMENTAL FACTORS WERE CONTRIBUTING TO THE LOSS OF PAIN CONTROL. A CATHETER DYE STUDY WAS PERFORMED, ON (B)(6) 2018, AND A LEAK WAS DETECTED. IT WAS NOTED THE PUMP ORIGINALLY DIDN'T ASPIRATE AND ONLY WHEN MANIPULATED DID FLUID START TO COME OUT. THERE WAS ALSO A LEAK AT THE ANCHOR SITE AT L1 WITH INTRATHECAL CONTRAST NOTED. A KINK WAS FOUND AT THE COLLETTE. IT WAS INDICATED THE EVENT WAS POSSIBLE RELATED TO THE DEVICE OR THERAPY AND UNLIKELY RELATED TO THE IMPLANT PROCEDURE. THE DEVICE DIAGNOSIS WAS CATHETER LEAKAGE AND THE CLINICAL DIAGNOSIS WAS INCREASE IN PAIN. THE PATIENT'S CATHETER WAS EXPLANTED AND NOT REPLACED ON (B)(6) 2018. IT WAS NOTED THE CATHETER WAS RETURNED TO THE MANUFACTURE. THE ISSUE RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. IT WAS NO

  Patient problems: Pain

  MAUDE report 7518610 ↗
• MalfunctionNov 9, 2016Bent; Connection Problem; Bent; Connection Problem

  INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURERS REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT WHEN THE PUMP CATHETER AND SPINAL CATHETER WERE BEING CONNECTED WITH THE CATHETER CONNECTOR, THEY COULDNT BE CONNECTED. THE METAL ON THE PART THAT THE CATHETER IS INSERTED INTO WAS BENT. THE HCP HAD SEEN THIS PROBLEM BEFORE, AND BECAUSE IT HAPPENED AGAIN, IT WAS COMMENTED THAT THIS SEEMED TO BE HAPPENING A LOT. THE ACCESSORY KIT WAS OPENED AND THE CONNECTION WAS ABLE TO BE DONE WITHOUT ANY PROBLEMS USING THE CONNECTOR INSIDE THE KIT. THERE WERE NO REPORTED SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6089787 ↗

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-0615-2024 · Nov 13, 2023 · Open, Classified
  Medtronic SynchroMed II, Model 8637-40, Programmable pump
• Z-0614-2024 · Nov 13, 2023 · Open, Classified
  Medtronic SynchroMed II, Model 8637-20, 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-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

…and 25 more.