Ascenda® 8780 (UDI 00643169783027)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169783027), received between May 1, 2018 and Feb 17, 2021 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A CLINICAL STUDY REPORTED THE CLINICAL DIAGNOSIS WAS UPDATED TO CSF LEAK. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Cerebrospinal Fluid Leakage; Fluid Discharge; Seroma

  MAUDE report 11337159 ↗
• InjuryJun 12, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT PATIENT¿S CATHETER WAS KINKED. IT WAS REPORTED THAT THE PATIENT WAS IN SURGERY FOR A POCKET REVISION BECAUSE THEY WERE GETTING READY TO HAVE A HERNIA SURGERY AND THE GENERAL SURGEON WANTED THE PUMP MOVED SLIGHTLY. THE CATHETER WAS FOUND TO NOT BE PATENT DURING THE SURGERY. IT WAS REPORTED THERE WAS NO FLOW WHEN ATTEMPTING TO ASPIRATE THROUGH THE SIDE PORT. IT WAS REPORTED THAT THE DOCTOR WAS ABLE TO UNKINK THE CATHETER AT THE ANCHOR SITED BY REMOVING THE ANCHOR. THE DOCTOR PLACED A NEW ANCHOR AND A NEW COLORED CONNECTOR AND WAS ABLE TO OBTAIN FLOW. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WERE REPORTED. THE PATIENT¿S STATUS WAS ALIVE WITH NO INJURIES. THE ISSUE WAS RESOLVED. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10148724 ↗
• MalfunctionDec 3, 2018Disconnection; Disconnection

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) ON (B)(6) 2018. IT WAS REPORTED THAT "2 8780 CATHET ERS WERE USED BECAUSE THERE WAS A PROBLEM WITH THE COLLETTE ON THE PUMP SEGMENT." THERE WERE NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8124840 ↗
• MalfunctionJul 17, 2018Retraction Problem; Material Deformation; Material Integrity Problem; Retraction Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A DEVICE MANUFACTURER REPRESENTATIVE REGARDING AN ISSUE WITH A 8780 CATHETER. IT WAS REPORTED THAT THE HCP PLACED THE CATHETER AND WHEN HE WENT TO REMOVE THE STYLET IT WOULD NOT SLIDE OUT EASILY SO HE ATTEMPTED TO PULL HARDER AND THE ENTIRE CATHETER AND STYLET KINKED. THE HCP THEN REQUESTED A NEW CATHETER. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. NO PATIENT WAS INVOLVED IN THIS EVENT. THE ISSUE WAS REPORTED AS RESOLVED. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7695356 ↗
• InjuryMay 31, 2018Material Integrity Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A CATHETER USED WITH AN IMPLANTED INFUSION PUMP. PER THE HCP, THE CATHETER WAS NOT USED AS IT BROKE DURING THE PROCEDURE AND IT WAS DISCARDED IN THE OR (OPERATING ROOM). THE HCP COULD NOT REMEMBER THE DATE OF THE EVENT OR MANY DETAILS, BUT NOTED THAT THEY DIDN'T THINK THERE WAS A DEFECT WITH THE CATHETER. THE HCP THOUGHT IT WAS THE PATIENT'S ANATOMY AS THE PATIENT WAS A CHILD. THE MANUFACTURER REPRESENTATIVE PRESENT AT THE CASE FURTHER NOTED THAT THE PHYSICIAN DAMAGED BOTH CATHETERS BY BENDING THEM BEFORE IMPLANTING THEM IN THE PATIENT. THE ACCOUNT REPORTEDLY FELT IT WAS USER ERROR SO THE CATHETER WAS NOT RETURNED. THE DEVICE WAS NEVER IMPLANTED, SO NO ADDITIONAL TUNNELING WAS REQUIRED. THERE WAS NO IMPACT TO THE PATIENT AND THE DEVICE WASN'T USED FURTHER. IT WAS SPECIFIED THAT THE IMPLANT WAS SUCCESSFUL. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7557247 ↗
• InjuryMay 31, 2018Material Integrity Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A CATHETER USED WITH AN IMPLANTED INFUSION PUMP. PER THE HCP, THE CATHETER WAS NOT USED AS IT BROKE DURING THE PROCEDURE AND IT WAS DISCARDED IN THE OR (OPERATING ROOM). THE HCP COULD NOT REMEMBER THE DATE OF THE EVENT OR MANY DETAILS, BUT NOTED THAT THEY DIDN'T THINK THERE WAS A DEFECT WITH THE CATHETER. THE HCP THOUGHT IT WAS THE PATIENT'S ANATOMY AS THE PATIENT WAS A CHILD. THE MANUFACTURER REPRESENTATIVE PRESENT AT THE CASE FURTHER NOTED THAT THE PHYSICIAN DAMAGED BOTH CATHETERS BY BENDING THEM BEFORE IMPLANTING THEM IN THE PATIENT. THE ACCOUNT REPORTEDLY FELT IT WAS USER ERROR SO THE CATHETER WAS NOT RETURNED. THE DEVICE WAS NEVER IMPLANTED, SO NO ADDITIONAL TUNNELING WAS REQUIRED. THERE WAS NO IMPACT TO THE PATIENT AND THE DEVICE WASN'T USED FURTHER. IT WAS SPECIFIED THAT THE IMPLANT WAS SUCCESSFUL. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7557239 ↗
• MalfunctionMay 1, 2018Device Damaged by Another Device; Device Damaged by Another Device

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A DEVICE MANUFACTURER REPRESENTATIVE REGARDING A PATIENT RECEIVING MORPHINE (30 MG/ML AT 2.4 MG/DAY) VIA AN IMPLANTABLE INFUSION PUMP. IT WAS REPORTED THAT THE CATHETER STYLET HAD TORN THROUGH THE CATHETER LUMEN DURING AN IMPLANTATION SURGERY ON (B)(6) 2018. A NEW CATHETER WAS OPENED AND USED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. NO SIGNS OR SYMPTOMS WERE REPORTED. THERE WERE NO KNOWN ENVIRONMENTAL, EXTERNAL OR PATIENT FACTORS WHICH MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE - NO INJURY. THE ISSUE WAS CONSIDERED RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7476037 ↗

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-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
• 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-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.