ASCENDA® 8781 (UDI 00763000051129)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000051129), received between Nov 16, 2018 and Nov 14, 2022 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 10, 2024Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WHO WAS RECEIVING UNKNOWN DRUG VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SPINAL HEAD AND REQUESTED A BLOOD PATCH TO MANAGE HEADACHE.

  Patient problems: Headache

  MAUDE report 15787301 ↗
• InjurySep 19, 2022Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING FENTANYL (2500 MCG ML/320 MCG DAY) VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE CATHETER WAS NOT WORKING. THE PATIENT HEALTHCARE PROVIDER (HCP) TRIED TO ASPIRATE THROUGH THE SIDE PORT UPON THE PATIENT COMPLAINING HE WAS NO LONGER GETTING ADEQUATE PAIN RELIEF. SHE WAS NOT ABLE TO OBTAIN FLUID THROUGH THE SIDE PORT. THE PATIENT HCP SCHEDULED SURGERY FOR (B)(6) 2022 AND TRIED TO ASPIRATE FROM THE PUMP SIDE PORT IN SURGERY AND WAS ALSO NOT ABLE TO ASPIRATE SO HE EXPLANTED THE OLD CATHETER AND IMPLANTED A NEW 8781 ASCENDA CATHETER. THE OLD CATHETER WAS X PLANTED IN A NEW CATHETER WAS IMPLANTED. THERE WAS NO ENVIRONMENTAL FACTOR/PATIENT FACTOR. THE PATIENT¿S MEDICAL HISTORY AND WEIGHT WAS ASKED BUT UNKNOWN. THE PATIENT STATUS WAS ALIVE-NO INJURY.THE ISSUE WAS RESOLVED.

  Patient problems: Pain

  MAUDE report 15449106 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT VIA HEALTHCARE PROVIDER WHO WAS RECEIVING MORPHINE (5MG/ML AT .55 MG/ML) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AT ST. VINCENT WITH COMPLAINTS RELATED TO CEREBRA SPINAL FLUID (CSF) LEAK. THE HEALTHCARE PROVIDER REMOVED OLD CATHETER AND REPLACED WITH A NEW 8781 CATHETER. PATIENTS DOG JUMPED ON HER. ENVIRONMENTAL FACTORS THAT HAVE LED TO THE ISSUE WAS THE PATIENT'S DOG JUMPED ON HER. THE ISSUE WAS RESOLVED AT TIME OF THE REPORT. PATIENT STATUS ALIVE NO INJURY.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 13795713 ↗
• MalfunctionApr 27, 2021Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION REPORTED THAT DURING A NEW PUMP IMPLANT, THE PHYSICIAN DAMAGED AN THE CATHETER. PER THE REPORTER, THE DAMAGE TO THE CATHETER WAS CAUSED AT THE SPINAL IMPLANT SITE. THE METAL WIRE WITHIN THE CATHETER FOR GUIDING HAD POPPED THROUGH THE CATHETER AND WAS POKING OUT OF THE OUTER LINING. THEY CORRECTED THE ISSUE WITH A NEW SPINAL SEGMENT. ADDITIONAL INFORMATION WAS RECEIVED ON 04-MAY-2021 FROM THE HEALTHCARE PROVIDER VIA THE COMPANY REPRESENTATIVE THAT REPORTED IN CLARIFICATION OF THE ISSUE THE PHYSICIAN WAS PLACING THE SPINAL SEGMENT OF THE CATHETER, THEN TOOK THE CATHETER OUT TO ADJUST THE SPINAL NEEDLE AND NOTICED THE SPINAL SEGMENT TIP WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11734131 ↗
• MalfunctionNov 12, 2020Material Integrity Problem; Insufficient Device Problem Information; Material Integrity Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE REGARDING AN OUT OF BOX FAILURE WITH AN ASCENDA ANCHOR CONNECTOR KIT. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURE REPRESENTATIVE REPORTED THE OUT OF BOX FAILURE WAS WITH THE ANCHOR IN THE 8781 KIT. IT WAS NOTED THE ANCHOR WAS BROKEN AND THE REP HAD TO OPEN THE 8785 AND USE THE ANCHOR TO REPLACE THE BROKEN ONE. IT WAS NOTED THE FAILURE OF THE ANCHOR SYSTEM WAS THAT THE STEEL PUSHING ROD THAT HOLDS THE ANCHOR CAME APART FROM THE PLASTIC OUTER HOUSING RENDERING IT UNUSABLE. IT WAS NOTED THERE WAS NO ISSUE WITH THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10829146 ↗
• MalfunctionNov 21, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING AN UNKNOWN DRUG WITH AN UNKNOWN CONCENTRATION AND UNKNOWN DAILY DOSE VIA AN IMPLANTABLE PUMP FOR AN UNKNOWN INDICATION FOR USE. IT WAS REPORTED THAT WHEN REMOVING THE GUIDEWIRE FROM THE CATHETER, THE CATHETER WAS REMOVED FROM THE GUIDEWIRE HANDLE AND THE GUIDEWIRE WITHOUT THE CATHETER WAS REMOVED. WHEN REMOVING THE CATHETER FROM THE GUIDEWIRE HANDLE, SOMETHING WHITE DROPPED AT THE SAME TIME. THERE WERE NO REPORTED PATIENT SYMPTOMS. IT WAS REPORTED THAT NO HEALTH DAMAGE TO THE PATIENT WAS REPORTED. THERE WERE NO REPORTED OR ANTICIPATED COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9355656 ↗
• MalfunctionApr 9, 2019Connection Problem; Connection Problem

  INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER'S REPRESENTATIVE REGARDING A PATIENT WHO WAS TO RECEIVE AN UNKNOWN DRUG VIA AN IMPLANTABLE PUMP FOR AN UNKNOWN INDICATION FOR USE. IT WAS REPORTED WHEN ATTEMPTING TO CONNECT THE CATHETER WITH THE CONNECTOR AND THE CONNECTOR WAS HELD, THE COLLET CAME OFF FROM THE CONNECTOR. THIS OCCURRED DURING THE PUMP IMPLANTATION PROCEDURE. IT WAS STATED AN ACCESSORY KIT WAS UNPACKED AND THE PROCEDURE WAS CONTINUED USING THE CONNECTOR IN THE KIT. THERE WAS NO REPORTED PATIENT IMPACT. FURTHER COMPLICATIONS WERE NOT REPORTED OR ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS UNDETERMINED IF ANY CONTRIBUTING FACTORS TO THE COLLET COMING OFF OF THE CONNECTOR WERE IDENTIFIED. THE PRODUCT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8496959 ↗
• MalfunctionFeb 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE ON (B)(6) 2019 REGARDING A CATHETER INTENDED FOR USE WITH AN IMPLANTED INFUSION PUMP. IT WAS REPORTED THAT AN ISSUE HAPPENED DURING SURGERY WHERE THREE COLLETS DID NOT WORK PROPERLY AND WOULD NOT CLAMP DOWN AS MUCH AS THE HCP WOULD LIKE. IT WAS NOTED THAT THEY ALSO SPLIT OPEN ON THE OTHER SIDE INSTEAD OF GETTING CLOSED. ONE SIDE DID WORK PROPERLY, AND THE OTHER SIDE DID NOT. NO PATIENT SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8305340 ↗
• MalfunctionJan 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A CATHETER. THE HCP THOUGHT THERE WAS AN ISSUE WITH THE CATHETER CONNECTOR COLLET. PER THE HCP, THE CONNECTION PIN SITE WAS DEFECTIVE, SO THE CATHETER WAS NOT IMPLANTED. PER THE HCP, THE TWO ENDS OF THE COLLET GROOVE SLIDE PIECES WHERE THE CATHETER SLIPS INTO PLACE WERE NOT SYMMETRICAL. THE HCP ALSO DIDN'T THINK THE CATHETER CONNECTOR WITH THE TWO COLLETS ON THE SIDE SHOULD HAVE THE SPACE IN THE MIDDLE. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8243503 ↗
• MalfunctionJan 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A CATHETER. THE HCP THOUGHT THERE WAS AN ISSUE WITH THE CATHETER CONNECTOR COLLET. PER THE HCP, THE CONNECTION PIN SITE WAS DEFECTIVE, SO THE CATHETER WAS NOT IMPLANTED. PER THE HCP, THE TWO ENDS OF THE COLLET GROOVE SLIDE PIECES WHERE THE CATHETER SLIPS INTO PLACE WERE NOT SYMMETRICAL. THE HCP ALSO DIDN¿T THINK THE CATHETER CONNECTOR WITH THE TWO COLLETS ON THE SIDE SHOULD HAVE THE SPACE IN THE MIDDLE. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8243501 ↗
• MalfunctionJan 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A CATHETER. THE HCP THOUGHT THERE WAS AN ISSUE WITH THE CATHETER CONNECTOR COLLET. PER THE HCP, THE CONNECTION PIN SITE WAS DEFECTIVE, SO THE CATHETER WAS NOT IMPLANTED. PER THE HCP, THE TWO ENDS OF THE COLLET GROOVE SLIDE PIECES WHERE THE CATHETER SLIPS INTO PLACE WERE NOT SYMMETRICAL. THE HCP ALSO DIDN¿T THINK THE CATHETER CONNECTOR WITH THE TWO COLLETS ON THE SIDE SHOULD HAVE THE SPACE IN THE MIDDLE. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8243499 ↗
• MalfunctionJan 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A CATHETER. THE HCP THOUGHT THERE WAS AN ISSUE WITH THE CATHETER CONNECTOR COLLET. PER THE HCP, THE CONNECTION PIN SITE WAS DEFECTIVE, SO THE CATHETER WAS NOT IMPLANTED. PER THE HCP, THE TWO ENDS OF THE COLLET GROOVE SLIDE PIECES WHERE THE CATHETER SLIPS INTO PLACE WERE NOT SYMMETRICAL. THE HCP ALSO DIDN¿T THINK THE CATHETER CONNECTOR WITH THE TWO COLLETS ON THE SIDE SHOULD HAVE THE SPACE IN THE MIDDLE. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8243498 ↗
• MalfunctionJan 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A CATHETER. THE HCP THOUGHT THERE WAS AN ISSUE WITH THE CATHETER CONNECTOR COLLET. PER THE HCP, THE CONNECTION PIN SITE WAS DEFECTIVE, SO THE CATHETER WAS NOT IMPLANTED. PER THE HCP, THE TWO ENDS OF THE COLLET GROOVE SLIDE PIECES WHERE THE CATHETER SLIPS INTO PLACE WERE NOT SYMMETRICAL. THE HCP ALSO DIDN'T THINK THE CATHETER CONNECTOR WITH THE TWO COLLETS ON THE SIDE SHOULD HAVE THE SPACE IN THE MIDDLE. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8243493 ↗
• MalfunctionNov 16, 2018Obstruction of Flow; Obstruction of Flow

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING THE PATIENT¿S IMPLANTABLE DRUG INFUSION DEVICE. THERE WAS NO DRUG BEING DELIVERED. THE REASON FOR USE WAS NOT REPORTED. IT WAS REPORTED THAT DURING A TRIAL FOR A PUMP IMPLANT ON (B)(6) 2018, THE DOCTOR BELIEVED THAT THE CATHETER KEPT KINKING AND WAS THEREFORE DEFECTIVE. THE CATHETER WAS PART OF A LARGE SHIPMENT OF PRE-ORDERED PRODUCTS THE HOSPITAL PURCHASED. THE FACILITY IS INTERESTED IN A CREDIT. ULTIMATELY, THE CATHETER WAS NEVER USED (NEVER IMPLANTED) AND DISCARDED. THE REPRESENTATIVE WAS UNAWARE THAT THE DISCARDED PRODUCT SHOULD BE RETURNED. THE PRODUCT WAS REPLACED WITH ANOTHER OF THE SAME MANUFACTURER. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THERE WERE NO DIAGNOSTICS/TROUBLESHOOTING PERFORMED. THERE WERE NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8077612 ↗

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-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-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-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.