ASCENDA® 8784 (UDI 00763000051143)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000051143), received between Feb 22, 2019 and Nov 3, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE WHO REPORTED THAT THE PHYSICIAN REQUESTED A DIFFERENT CATHETER BECAUSE HE SAID THE COLLET WAS BROKEN ON THE ONE OUT OF THE PACKAGE. IT WAS UNKNOWN IF THERE WERE ANY ENVIRONMENTAL OR EXTERNAL FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PHYSICIAN WAS GIVEN A DIFFERENT CATHETER. THE ISSUE WAS NOTED TO BE RESOLVED, AND IT WAS INDICATED THAT THE HCP HAD NO FURTHER INFORMATION TO PROVIDE REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12743570 ↗
• MalfunctionAug 24, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED BY A HEALTHCARE PROVIDER (HCP) VIA COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS RECEIVING DILAUDID (UNKNOWN CONCENTRATION OR DOSE) VIA IMPLANTABLE INFUSION PUMP. IT WAS REPORTED THAT THE COLLET WAS BROKEN DURING THE PROCEDURE PRIOR TO IMPLANT. THERE WERE NO KNOWN FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. TROUBLESHOOTING WAS NOT PERFORMED. A NEW KIT WITH A NEW COUPLER WAS OPENED. THE ISSUE WAS RESOLVED AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362693 ↗
• MalfunctionFeb 22, 2019Connection Problem; Connection Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE ON (B)(6) 2019 REGARDING A PATIENT RECEIVING GABLOFEN (500MCG/ML AT 50MCG/DAY) VIA AN IMPLANTED INFUSION PUMP. THE INDICATION FOR USE WAS INTRACTABLE SPASTICITY. THE PATIENT'S MEDICAL HISTORY INCLUDED SEVERE SPASTICITY. IT WAS REPORTED THAT THE ATTACHED COLLETS ON THE CATHETER INCLUDED IN THE KIT DETACHED FROM THE CONNECTOR WHEN THE SURGEON WAS HANDLING IT. THE SURGEON WAS TRYING TO CONNECT THE PUMP SEGMENT TO THE SPINAL SEGMENT AT THE SPINE INCISION AND THE COLLETS FELL OFF. THE PATIENT WAS NOT EXPERIENCING ANY ISSUES BECAUSE OF THIS. NO DIAGNOSTICS OR TROUBLESHOOTING WERE PERFORMED AND THERE WERE NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. A NEW KIT WAS OPENED AND THE CONNECTOR WAS REPLACED DURING THE IMPLANT PROCEDURE WITH A NEW ONE. THE ISSUE WAS RESOLVED AT THE TIME OF REPORT AND THE PATIENT'S STATUS WAS ALIVE - NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8362673 ↗

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.