Ascenda™ 8781Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169202139), received between Jan 6, 2017 and Apr 11, 2018 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (5 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.

• MalfunctionApr 11, 2018Connection Problem; Device Operates Differently Than Expected; Connection Problem; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL (HCP) VIA A BUSINESS PARTNER REGARDING A PATIENT IN (B)(6). THE INDICATION FOR USE SPASTICITY. IT WAS REPORTED THAT THE COLLECT OF THE CATHETER CONNECTOR IN THE ASCENDA KIT CAME OFF. AS FURTHER CLARIFIED, WHEN AN ATTEMPT WAS MADE TO CONNECT THE SPINAL SIDE CATHETER AND THE PUMP SIDE CATHETER USING A CATHETER CONNECTOR DURING THE INITIAL PUMP IMPLANTATION OPERATION, THE COLLET WAS FOUND ¿TO BE COME OFF¿ FROM THE CONNECTOR. IN THIS FACILITY, THE PACKAGE OF THE ASCENDA CATHETER SET WAS UNPACKED BY A NURSE, AND NOT THE BUSINESS PARTNER REPRESENTATIVE. THEREFORE THE BUSINESS PARTNER REPRESENTATIVE COULD NOT CONFIRM THE DEFECT OF THE PRODUCT AT THAT TIME. THE PRODUCT WAS NEVER IMPLANTED. THE CAUSALITY WAS ASSOCIATED TO THE PRODUCT ITSELF. THIS PRODUCT WAS REPLACED WITH ANOTHER BACK-UP ACCESSORY KIT. PATIENT SYMPTOMS WERE NOT REPORTED. AT THE TIME OF THE REPORT THE ISSUE WAS RESOLVED AND THE PATIENT¿S STATUS WAS REPORTED AS ALIVE-NO INJURY. AS REPORTED, IT WAS UNKNOWN IF THERE WERE ANY ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE EVENT. THE CAUSE COULD NOT BE SPECIFIED ¿ON THE SPOT¿. AS REPORTE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7422796 ↗
• MalfunctionNov 30, 2017Connection Problem; Connection Problem

  ON (B)(6) 2017, INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROFESSIONAL (HCP) VIA (B)(6). NO PATIENT INFORMATION OR DRUG INFORMATION WAS RECEIVED. ON (B)(6) 2017, DURING AN OPERATION, THE SPINAL CATHETER AND THE PUMP CATHETER WERE ATTEMPT TO BE CONNECTED USING A CATHETER CONNECT (COLLET), BUT ONE SIDE OF THE COLLET WAS TIGHT SO THAT THE CATHETER WAS UNABLE TO BE INSERTED PROPERLY. DETAILS OF THE ACTUAL PRODUCT OF COMPLAINT STATED, "REGARDING ONE SIDE OF THE COLLET, THE CATHETER WAS INSERTED IN THE WHOLE AND LOCKED. THE OTHER SIDE OF THE COLLET WHICH WAS TIGHT WAS ALREADY LOCKED AS WELL. THE PHYSICIAN WAS WELL EXPERIENCED AS HE PERFORMED THE PROCEDURE IN MORE THAN 15 CASES." BECAUSE THE CATHETER WAS UNABLE TO BE INSERTED PROPERLY, A CATHETER CONNECTOR IN AN ACCESSORY KIT WAS UNPACKED AND USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7072951 ↗
• MalfunctionNov 29, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  ON (B)(6) 2017, INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROFESSIONAL (HCP) VIA DAIICHI. NO PATIENT OR DRUG INFORMATION WAS PROVIDED. ON (B)(6) 2017, DURING A PROCEDURE, THE CATHETER COLLET CAME OFF WHEN GRIPPED. DETAILS OF THE ACTUAL PRODUCT OF COMPLAINT STATED, "THE COLLET OF CAME OFF FROM THE CATHETER CONNECTOR". COMMENT/REQUEST FROM THE CUSTOMER STATED, "NOTHING IN PARTICULAR BECAUSE A CONNECTOR IN AN ACCESSORY KIT WAS UNPACKED AND USED". NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7068396 ↗
• MalfunctionNov 21, 2017Component Missing; Device Operates Differently Than Expected; Component Missing; Device Operates Differently Than Expected

  ON 2017-OCT-26, INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROFESSIONAL (HCP) VIA DAIICHI REGARDING A PATIENT RECEIVING AN UNKNOWN DRUG FROM AN IMPLANTABLE PUMP FOR AN UNKNOWN INDICATION FOR USE. ON (B)(6) 2017, DURING THE PROCEDURE, WHEN THE HCP ATTEMPTED TO CONNECT THE SPINAL SIDE CATHETER AND THE PUMP SIDE CATHETER USING THE CATHETER CONNECTOR, THE HCP NOTICED THAT ONE COLLET WAS MISSING. SEVERAL OTHER HCPS LOOKED FOR THE MISSING COLLEGE ON THE STERILE CATHEROSTAT BUT COULD NOT FIND IT. FURTHER DETAILS OF THE ACTUAL PRODUCT COMPLAINT STATED, "ONE COLLET WAS MISSING ALTHOUGH COLLETS SHOULD HAVE BEEN ATTACHED TO EACH CATHETER CONNECTOR ON THE BOTH SIDES." NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED AND/OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7050754 ↗
• MalfunctionOct 19, 2017Connection Problem; Device Operates Differently Than Expected; Connection Problem; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING LIORESAL 2000 MCG/ML AT 150 MCG / DAY VIA AN IMPLANTABLE PUMP. THE INDICATIONS FOR USE WERE NOT REPORTED. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER WAS UNABLE TO GET THE SPINAL SECTION OF THE CATHETER ONTO THE CONNECTION PIN. THE HEALTHCARE PROVIDER MADE SEVERAL ATTEMPTS WITHOUT BEING SUCCESSFUL. AT SOME POINT THE COLLET ON THE SPINAL SIDE FELL APART FROM THE REST OF THE CONNECTOR. WHEN ASKED IF THERE WERE ANY ENVIRONMENTAL, EXTERNAL OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE THE REPORTER DID NOT BELIEVE THE HEALTHCARE PROVIDER HANDLED THE CATHETER OR THE CONNECTOR ROUGHLY. THERE WAS NO TROUBLESHOOTING PERFORMED. THE COMPANY REPRESENTATIVE WENT AND GOT AN 8785 TO REPLACE THE BROKEN CONNECTOR. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE PATIENT STATUS WAS NOTED AS ALIVE, NO INJURY AND NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6962895 ↗
• MalfunctionAug 17, 2017Device Operates Differently Than Expected; Material Integrity Problem; Device Operates Differently Than Expected; Material Integrity Problem

  ON (B)(6) 2017, ADDITIONAL INFORMATION WAS RECEIVED FROM A FOREIGN MANUFACTURER REPRESENTATIVE (REP). ADDITIONAL INFORMATION CONFIRMED THAT A NEW CATHETER WAS USED. THE DEVICE SN/MODEL WAS UNKNOWN. ADDITIONAL INFORMATION ALSO CONFIRMED THAT THE CATHETER ISSUE DID NOT RESULT IN ANY PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6800658 ↗
• MalfunctionJan 6, 2017Material Integrity Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO RECEIVED MORPHINE (10 MG/ML, UNKNOWN DOSE) IN AN IMPLANTABLE PUMP FOR AN UNKNOWN INDICATION FOR USE. THE CATHETER WAS OBSERVED TO HAVE A DAMAGED TIP AFTER REMOVAL FROM THE INTRODUCER NEEDLE DURING THE PUMP IMPLANT PROCEDURE ON (B)(6) 2017. ALL PARTS LOOKED INTACT AND A NEW CATHETER WAS IMPLANTED. THERE WERE NO REPORTED UNUSUAL SIGNS OR SYMPTOMS REPORTED BY THE PATIENT OR HCP POST PROCEDURE. THERE WERE NO KNOWN ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE ISSUE WAS CONSIDERED RESOLVED AS OF (B)(6) 2017. THE STATUS OF THE PATIENT WAS STATED TO BE ALIVE AND WITH NO INJURY. THE CATHETER WAS NOT IMPLANTED AND WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6228390 ↗

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-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
• 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.