Ascenda® 8784 (UDI 00763000916671)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000916671), received between Jan 22, 2025 and Sep 28, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 4 most recent of 4 reports, 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 ↗
• 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 ↗
• MalfunctionJan 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 2025-JAN-16, INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP), REGARDING A PATIENT RECEIVING MORPHINE (10 MG/ML, 1.299 MG) AND BUPIVACAINE (5 MG/ML, 0.6497) VIA AN IMPLANTABLE PUMP. IT WAS REPORTED A PUMP PROCEDURE (SEE RELATED EVENT), WHILE USING A 8784 TO TUNNEL A NEW PUMP SEGMENT TO NEW POCKET, THE COLLET OR "MUSHROOM PART THAT CLAPS THE CATHETER" FELL / BROKE OFF WHEN THE HEALTHCARE PROFESSIONAL (HCP) WAS THREADING THE CATHETER INTO THE COLLET. THE REP REPORTED THERE WAS NO "ROUGH PLAY" AS THEY WERE "WATCHING THE WHOLE TIME". A NEW 8784 WAS OPENED TO GET A NEW COLLET. THE REPORTED ACTIONS / INTERVENTIONS THAT TOOK PLACE TO RESOLVE THE EVENT WERE "HAD TO UTILIZE 2 DIFFERENT 8784 IN ORDER TO CONNECT NEW PUMP SEGMENT TO ALREADY PLACED SPINAL SEGMENT. THE CATHETER WAS ATTACHED AND THE PUMP SEGMENT WAS ATTACHED TO THE PUMP WITH EASY ASPIRATION OF CEREBROSPINAL FLUID (CSF). THE POCKET WAS CLOSED WITH EVERYTHING RUNNING AS IT SHOULD. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21211866 ↗

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-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-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.