ASCENDA® 8780 (UDI 00763000051112)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00763000051112), received between Feb 6, 2019 and Aug 14, 2026 — classified as 2 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (11 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260237 ↗
• MalfunctionMay 10, 2024Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PREVIOUSLY REPORTED INFORMATION ON 2024-05-09 WAS CONFIRMED WITH THE PHYSICIAN ACCOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19293570 ↗
• MalfunctionApr 22, 2024Difficult to Advance; Difficult to Advance

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING AN IMPLANTABLE PUMP. THE INDICATIONS FOR USE WERE UNKNOWN. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN TRIED TO THREAD THE CATHETER AND IT WOULD NOT GO THROUGH THE NEEDLE. THEY PULLED THE ENTIRE NEEDLE OUT TO INVESTIGATE IT AND THE CATHETER WAS STILL STUCK IN THE NEEDLE. THERE WERE NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE CATHETER AND NEEDLE WERE BEING RETURNED. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. IT WAS NOTED THAT THE HCP HAD NO FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154764 ↗
• InjuryMar 18, 2024Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION PROVIDED BY THE REP INDICATED THAT PART OF THE PROBLEM WAS THAT THE PHYSICIAN DIDN¿T GET/TAKE AN X-RAY. THE PHYSICIAN PUT THE NEEDLE IN REALLY FAST AND THE REP TOLD THEM THAT THEY NEEDED TO GET AN X-RAY FIRST AND THE PHYSICIAN SAID ¿YEAH¿. THE PHYSICIAN ORDERED THE X-RAY BUT BEFORE THE X-RAY, HE PULLED OUT THE NEEDLE AND BLOOD WAS SHOOTING OUT OF THE PATIENT WITH VELOCITY ONTO THE PHYSICIAN¿S APRON. WHEN HE BACKED OFF THE TABLE HE SAID ¿I THINK I HIT THE AORTA¿. THE PHYSICIAN LEFT THE NEEDLE IN PLACE AND CALLED FOR THE VASCULAR TEAM TO COME IN AND CLOSE THE HOLE. THE REP REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE, WAS ALERT AND ORIENTED WHEN WAKING UP FROM IT. IT WAS NOTED THIS WAS A QUAD PATIENT AS PART OF THEIR MEDICAL HISTORY. THERE WERE NO SEQUELAE AS A RESULT OF THE SURGERY. THE PATIENT DIDN¿T EXPERIENCE ANY ISSUES RELATED TO THE AORTA PUNCTURE. THE REP WAS IN ATTENDANCE AT THEIR NEXT IMPLANT PROCEDURE AND REP INDICATED THAT THERE WAS NOTHING WRONG WITH THE PRODUCT (NEEDLE/STYLET) AND THAT IT WAS A USER ERROR CAUSED BY THE LACK OF TAKING HIS TIME AND NOT TAKING AN X-RAY. THE REP NOTED WHEN VIEWING THE X-RAY IT LOOKED LIKE IT HAD JUST G ONE STRAIGH

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 18922148 ↗
• MalfunctionNov 22, 2023Connection Problem; Insufficient Device Problem Information; Connection Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A COMPANY REPRESENTATIVE (REP) REGARDING AN OUT OF BOX ISSUE OF A CATHETER DURING A PROCEDURE. IT WAS REPORTED THAT THE PUMP SEGMENT WAS DEFECTIVE OUT OF BOX. IMPLANTED NOT ABLE TO CONNECT SPINE SEGMENT TO PUMP SEGMENT. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. NO DIAGNOSTICS/TROUBLESHOOTING WAS PERFORMED. IN ORDER TO RESOLVE THE ISSUE THEY USED AN 8784 PUMP SEGMENT INSTEAD. THE EVENT WAS RESOLVED AT THE TIME OF THIS REPORT. NO PATIENT INVOLVED IN EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18192524 ↗
• MalfunctionNov 3, 2023Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE (REP) INDICATED THAT MORPHINE 9.507 MG/DAY 20 MG/ML AND BUPIVACAINE 2.37 MG/DAY 5.0. MG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066172 ↗
• MalfunctionJun 21, 2023Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIV ING AN UNKNOWN DRUG VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT AT A NEW IMPLANT CASE TODAY, THE HEALTHCARE PROVIDER (HCP) ATTEMPTED TO DOUBLE CHECK THAT CEREBROSPINAL FLUID (CSF) COULD BE ASPIRATED FROM CATHETER BUT THEY WERE UNABLE TO ASPIRATE. THEY THEN TOOK THE CATHETER OUT AND ATTEMPTED TO FLUSH IT BUT THEY WERE STILL UNABLE. THE HCP ENDED UP USING A DIFFERENT CATHETER. TECHNICAL SERVICES DISCUSSED OCCLUSION IN EITHER THE CATHETER OR NEEDLE; THE COMPANY REPRESENTATIVE CONFIRMED THE HCP DID NOT TRY USING ANOTHER NEEDLE. DISCUSSED SENDING CATHETER BACK FOR ANALYSIS TO SEE IF THERE WAS AN ISSUE IN MANUFACTURING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17170699 ↗
• MalfunctionMar 27, 2023Material Integrity Problem; Positioning Problem; Material Integrity Problem; Positioning Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REPRESENTATIVE REPORTED THAT THE GUIDEWIRE WAS COMING OUT OF THE SIDE OF THE CATHETER BODY NEAR THE TIP AT THE OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16622388 ↗
• MalfunctionMar 22, 2023Infusion or Flow Problem; Insufficient Device Problem Information; Infusion or Flow Problem; Insufficient Device Problem Information

  ON (B)(6) 2023, INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONALS (HCP), VIA AN MANUFACTURER REPRESENTATIVE (REP), REGARDING A PATIENT RECEIVING BACLOFEN (2,000 MCG/ML, 1,869.0 MCG/DAY) VIA AN IMPLANTABLE PUMP. IT WAS REPORTED A NEW 8780 CATHETER WAS IMPLANTED AND SPONTANEOUS CEREBROSPINAL FLUID (CSF) FLOW BRISKLY FROM THE CATHETER. AFTER INSERTING THE ANCHOR ON THE NEW 8780, AND DEPLOYED ONTO THE CATHETER, IT CAUSED ABRUPT STOP IN THE CSF FLOW FROM THE CATHETER. THIS ANCHOR WAS REMOVED AND BRISK FLOW RE-STARTED. THIS PORTION OF THE NEW CATHETER AND ANCHOR WERE BEING SENT BACK FOR ANALYSIS. A NEW ANCHOR WAS RE-APPLIED, AND CSF FLOW REMAINED SPONTANEOUS AND NO ISSUES NOTED WITH THE NEW 8785 ANCHOR. THE HCP NOTED THE ANGLE OF THE ANCHOR AS IT WAS DEPLOYED WAS THE SAME AS HIS NEEDLE ENTRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16593928 ↗
• MalfunctionDec 9, 2022Material Integrity Problem; Insufficient Device Problem Information; Material Integrity Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT, PRIOR TO A PUMP IMPLANT, THE CIRCULATOR STAFF MEMBER PASSED A NEW CATHETER TO THE SCRUB NURSE. WHEN THE NURSE OPENED THE CATHETER, THE GUIDEWIRE WAS PUSHED THROUGH THE TIP OF THE CATHETER. THE CATHETER WAS DISCARDED AND A DIFFERENT CATHETER WAS USED FOR THE IMPLANT. ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WERE NO APPLICABLE. DIAGNOSTICS/TROUBLESHOOTING PERFORMED WERE NOT APPLICABLE. AT THE TIME OF THE REPORT, THE ISSUE WAS RESOLVED AND THE PATIENT STATUS WAS "ALIVE-NO INJURY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15955031 ↗
• MalfunctionNov 14, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE REGARDING AN IMPLANTABLE CATHETER. THE COMPANY REPRESENTATIVE STATED AN 8780 CATHETER WAS MAILED TO THEM TODAY AND THE BOX THAT IT WAS SHIPPED IN WAS DAMAGED AND THE ONE 8780 WAS WET AND NOT USABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788349 ↗
• MalfunctionMay 7, 2022Material Integrity Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING AN IMPLANTABLE DEVICE TH AT HAS NOT BEEN IMPLANTED. IT WAS REPORTED THAT THE HCP STATED THAT THE CATHETER WAS TOO BENT TO IMPLANT IN PATIENT. THE CATHETER WAS UNABLE TO THREAD FOR PLACEMENT. THERE WERE NO KNOWN FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. IT WAS UNKNOWN IF ANY DIAGNOSTICS/TROUBLESHOOTING WAS PERFORMED. A NEW CATHETER WAS OPENED AND USED FOR THE PROCEDURE. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14326635 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIVING FENTANYL, MORPHINE AND BUPIVACAINE VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY. IT WAS REPORTED THAT THE PATIENT HAD DISCOMFORT OVER THEIR PUMP SITE SO THE PUMP WAS MOVED TO THEIR BACK.

  MAUDE report 13768772 ↗
• MalfunctionMar 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING AN DEVICE PRE-IMPLANT. IT WAS REPORTED THAT WHEN THEY OPENED AN 8780 TO USE FOR SURGERY THE END CAP WAS OFF THE COLLET ON THE PROXIMAL PIECE OF THE CATHETER. THE REP STATED THAT THEY WERE UNSURE IF IT WAS THAT WAY WHEN THEY OPENED THE PACKAGE OR IF SOMEBODY ACCIDENTALLY PULLED THE CAP OFF THE COLLET. THEY ENDED UP USING A DIFFERENT COLLET FROM ANOTHER CATHETER. NO SYMPTOMS/PATIENT COMPLICATION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13668717 ↗
• MalfunctionJan 21, 2022Material Integrity Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING AN INTRATHECAL CATHETER. IT WAS REPORTED THAT THE CATHETER PACKAGE WAS OPENED ON THE BACK TABLE FOR AN IMPLANT AND THE SURGERY TECHNICIAN NOTICED THAT THE STYLET WAS PUNCTURED THROUGH THE CATHETER TIP. IT WAS NEVER PLACED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13315171 ↗
• MalfunctionOct 29, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIVING UNKNOWN DRUG VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE COLLET ON THE PUMP SEGMENT WAS CRACKED.  IT WAS VISIBLE THAT IT WAS CRACKED AND COULD NOT BE USED.  IT WAS REPLACED WITH ANOTHER CATHETER PUMP SEGMENT.  THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12721359 ↗
• MalfunctionSep 20, 2021Material Integrity Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING AN ISSUE WITH A CATHETER IMPLANT. IT WAS REPORTED THAT THE NEWLY OPENED CATHETER WAS SHEARED AND UNABLE TO BE USED. IT WAS NOTED THAT THE DEVICE WOULD BE SENT BACK FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12498969 ↗
• MalfunctionSep 8, 2021Retraction Problem; Retraction Problem

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL (HCP) VIA A DEVICE MANUFACTURER REPRESENTATIVE REGARDING A PATIENT RECEIVING SALINE VIA AN IMPLANTABLE INFUSION PUMP. IT WAS REPORTED THAT DURING INITIAL CATHETER PLACEMENT, THE HCP WAS UNABLE TO WITHDRAW THE STYLET FROM THE CATHETER. MULTIPLE ATTEMPTS WERE MADE, BUT THE STYLET COULD NOT BE REMOVED. A NEW CATHETER SET WAS UTILIZED AND THE ISSUE WAS RESOLVED. THERE WERE NO ENVIRONMENTAL, EXTERNAL OR PATIENT FACTORS WHICH MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. NO FURTHER COMPLICATIONS WERE REPORTED. 2021-07-07 RP: DOCUMENT CONTAINED NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12438396 ↗
• MalfunctionAug 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING PRIALT (25 MCG/ML, 1.2 MCG/DAY) VIA AN IMPLANTABLE PUMP FOR AN UNKNOWN INDICATION OF USE. IT WAS REPORTED THAT WHEN THE PHYSICIAN HAD PICKED UP THE ANCHOR TO IMPLANT, IT WAS NOT ATTACHED AS EXPECTED TO THE DEPLOYMENT TOOL. THE ANCHOR WAS HANGING TO THE SIDE WITH THE GREEN PIECE OUTSIDE OF THE ANCHOR TOOL. INSTEAD OF TRYING TO UTILIZE, AN 8785 WAS OPENED AND IMPLANTED. THERE WERE NO KNOWN ENVIRONMENTAL/EXTERNAL FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. THE PATIENT'S MEDICAL HISTORY INCLUDED DIABETES, NO OTHER KNOWN MEDICAL HISTORY. THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12355676 ↗
• MalfunctionJun 8, 2021Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  INFORMATION WAS RECEIVED BY A HEALTHCARE PROVIDER (HCP) VIA COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING UNKNOWN DRUG VIA IMPLANTABLE INFUSION PUMP. IT WAS REPORTED THAT DURING THE INTRATHECAL BACLOFEN (ITB) IMPLANT, THE PHYSICIAN USED THE NEEDLE TO GET INTRATHECAL ACCESS. WHEN THE PHYSICIAN ADVANCED THE CATHETER, THE CATHETER LOOPED AND TRAVELED CAUDAL RATHER THAN CEPHALAD. WHEN THE PHYSICIAN TRIED TO PULL THE CATHETER BACK IT GOT STUCK ON THE NEEDLE. THE FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WAS UNKNOWN. A NEW CATHETER AND NEEDLE WAS OPENED AND SHE ENTERED THE INTRATHECAL SPACE MORE MEDIALLY AND WAS ABLE TO ADVANCE THE NEW CATHETER WITHOUT COMPLICATIONS. THE ISSUE WAS RESOLVE AT THE TIME OF REPORT. THE PATIENT'S WEIGHT WAS ASKED AND WILL NOT BE MADE AVAILABLE. THE PATIENT'S MEDICAL HISTORY INCLUDES MULTIPLE SCLEROSIS. THE PATIENT'S STATUS AT THE TIME OF REPORT WAS ALIVE - NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959851 ↗
• MalfunctionApr 27, 2021Difficult to Advance; Difficult to Advance

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER WAS UNABLE TO BE STEERED APPROPRIATELY. A NEW CATHETER WAS OPENED AND WORKED FINE. THE CATHETER WAS NEVER IMPLANTED. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11734794 ↗
• MalfunctionApr 7, 2021Retraction Problem; Retraction Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER AND A CONSUMER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING MORPHINE 1MG/ML AT APPROXIMATELY .78MG/DAY VIA AN IMPLANTABLE PUMP. THE OTHER MEDICATIONS THE PATIENT WAS TAKING AT THE TIME OF THE EVENT WAS HYDROCODONE. IT WAS REPORTED THAT AT THE INITIAL PUMP AND CATHETER IMPLANT PROCEDURE THE CATHETER WAS IMPLANTED/EXPLANTED. THE PHYSICIAN PLACED THE CATHETER INTRATHECAL VIA THE SPINAL NEEDLE IN THE 8780 KIT. WHEN ATTEMPTING TO REMOVE THE SPINAL NEEDLE, AFTER THE PLACEMENT OF THE CATHETER, THE PHYSICIAN COULD NOT REMOVE THE SPINAL NEEDLE WITHOUT PULLING THE CATHETER WITH THE NEEDLE. THE DOCTOR STRUGGLED TRYING TO KEEP THE CATHETER IN PLACE WHILE REMOVING THE SPINAL NEEDLE AND IN DOING SO WAS NOT CONFIDENT THE INTEGRITY OF THE CATHETER WAS GOOD. THEREFORE, THE DOCTOR REQUESTED ANOTHER 8780 CATHETER TO BE OPENED AND USED. THE FIRST 8780 CATHETER USED WAS NOT IMPLANTED. THIS WAS NOT A REPLACEMENT OR REVISION PUMP/CATHETER PROCEDURE. THIS WAS THE INITIAL PUMP AND CATHETER PLACEMENT FOR THE PATIENT. TWO CATHETERS WERE OPENED FOR THE CASE. ONE CATHETER WAS IMPLANTED AND THEN EXPLANTED. THE OTHER CATHETER WAS I MPLANTED. THE E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628528 ↗
• MalfunctionJan 22, 2021Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER VIA A DEVICE MANUFACTURER REPRESENTATIVE REGARDING A PATIENT RECEIVING THERAPY VIA AN IMPLANTABLE INFUSION PUMP. IT WAS REPORTED THAT DURING AN IMPLANT SURGERY THE CATHETER WAS UNABLE TO BE ASPIRATED. REPLACEMENT OF THE CONNECTOR PIECE USING AN 8785 ACCESSORY KIT WAS SUGGESTED. THE PHYSICIAN THEN ATTEMPTED TO ASPIRATE FROM THE CATHETER ACCESS PORT (CAP) OF THE PUMP ONCE THE CATHETER WAS AGAIN ATTACHED TO THE PUMP AND WAS STILL NOT ABLE TO ASPIRATE THE CATHETER. FLUID WAS ALSO UNABLE TO BE INFUSED INTO THE CATHETER. UPON FURTHER INSPECTION AT THE SPINE SURGICAL SITE, IT WAS FELT THAT THE CATHETER WAS NO LONGER IN THE INTRATHECAL SPACE. A NEW CATHETER WAS USED AND THE INITIAL CATHETER WAS DISCARDED OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11215450 ↗
• MalfunctionDec 30, 2020Difficult to Advance; Difficult to Advance

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURE REPRESENTATIVE REGARDING A PATIENT RECEIVING UNKNOWN DRUG VIA AN IMPLANTED INFUSION PUMP. IT WAS REPORTED THE PATIENT WAS BROUGHT TO THE OR FOR IMPLANTATION OF A NEW INTRATHECAL ASCENDA CATHETER AND SYNCHROMED II DRUG PUMP. AFTER SEVERAL ATTEMPTS TO PASS THE CATHETER INTO THE INTRATHECAL SPACE, THE CASE WAS ABORTED AS THE CATHETER WOULD NOT THREAD. IT WAS NOTED THE ISSUE WAS NOT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096449 ↗
• MalfunctionDec 17, 2020Difficult to Advance; Infusion or Flow Problem; Difficult to Advance; Infusion or Flow Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER INDICATED THAT THE CAUSE OF THE ASPIRATION ISSUE WAS UNKNOWN. IT WAS REPORTED THAT A DISCHARGE PROCEDURE WAS PERFORMED TO RESOLVE THE PATIENT'S SYMPTOMS.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11026435 ↗

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.