NA 8598ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169887657), received between May 20, 2021 and Apr 5, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).

40 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2023Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIVE ING UNKNOWN DRUG VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT AT IMPLANT THE STYLET IN THE CATHETER AFTER ATTEMPTING TO IMPLANT BECAME VERY WEAK AND BENT. THEY WERE UNABLE TO USE THE STYLET ANDA NEW CATHETER WAS NEEDED. IT WAS UNKN OWN IF THERE WERE ANY FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE EVENT WAS RESOLVED AT THE TIME OF REPORTED. THE PATIENT'S WEIGHT WAS ASKED BUT UNKNOWN. THE PATIENT'S STATUS AT THE TIME OF REPORT WAS LISTED AS "ALIVE - NO INJURY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16684077 ↗
• InjuryMay 20, 2021Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) AND A CONSUMER VIA A CLINICAL STUDY AND A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING MORPHINE 20 MG FOR A TOTAL DOSE OF 5.49908 MG/DAY AND BUPIVACAINE 7.3 MG FOR A TOTAL DOSE OF 2.00716 MG/DAY VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THE PATIENT REPORTED INCREASED PAIN OVER THE PAST THREE MONTHS. ON (B)(6) 2021 THE PATIENT HAD A CATHETER DYE STUDY (CDS). THE CDS FAILED AS THEY WERE UNABLE TO ASPIRATE THE CATHETER. FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE EVENT INCLUDED A POSSIBLE FALL. THE SURGICAL PROCEDURE WAS REVISION/REPLACEMENT OF INTRATHECAL CATHETER AND POSSIBLE REVISION OF PUMP POCKET SITE. THE SPINAL CATHETER WAS EXPLANTED/REPLACED ON (B)(6) 2021. AT TIME OF SURGERY IT WAS NOTED THE SPINAL CATHETER WAS OCCLUDED AND THEY WERE UNABLE TO ASPIRATE. THE OUTCOME OF THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2021. THE PATIENT'S STATUS AT TIME OF REPORT WAS ALIVE- NO INJURY. THE DEVICE DIAGNOSIS WAS PUMP UNABLE TO ENTER/WITHDRAW FROM CATHETER ACCESS PORT AND CATHETER OCCLUSION. THE PUMP WAS IN THE LEFT UPPER BUTTOCK AND THE CATHETER TIP WAS T7. THE ETIOLOGY OF THE EVENT INDICATED THE RELAT

  Patient problems: Pain

  MAUDE report 11859870 ↗

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-2352-2024 · May 10, 2024 · Open, Classified
  Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
• 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

…and 25 more.