SYNCHROMED™ III 8667-40 (UDI 00763000597030)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,421 adverse event reports that list this exact device (DI 00763000597030), received between Jan 5, 2024 and Sep 30, 2026 — classified as 2 deaths, 630 injuries, 789 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (616 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,421 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Insufficient Device Problem Information

  Patient problems: Cramp(s) /Muscle Spasm(s); High Blood Pressure/ Hypertension; Tachycardia

  MAUDE report 50952752 ↗
• MalfunctionSep 30, 2026Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951370 ↗
• MalfunctionSep 30, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950862 ↗
• MalfunctionSep 30, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950818 ↗
• MalfunctionSep 30, 2026Application Program Problem; Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950672 ↗
• MalfunctionSep 30, 2026Application Program Freezes or Fails to Launch

  Information was received from a patient who was receiving Unknown Drug via an implantable pump for non-malignant pain indications for use. It was reported that their handset was lagging when connecting to the myPTM app. When asked for event date it 'seemed to start not very long, short weeks after' them getting the device. Agent walked the patient through clearing the data. Pt confirmed they were able to connect without lag. Troubleshooting steps taken on the call resolved the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950631 ↗
• MalfunctionSep 30, 2026Pumping Stopped

  Information was received from a healthcare provider via company representative regarding a patient with an implantable pump containing Baclofen (Unknown). It was reported that the patient's pump was having motor stalls. It was not known if there were any environme ntal/external/patient factors that may have led or contributed to the issue. The patient had denied any magnets. No interventions have been planned as of yet and it was reported that the event has not been resolved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947873 ↗
• InjurySep 29, 2026Migration or Expulsion of Device; Infusion or Flow Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 50938042 ↗
• MalfunctionSep 29, 2026Migration or Expulsion of Device; Ambient Temperature Problem

  Information was received from a healthcare provider and a manufacturing representative regarding a patient was receiving unknown Morphine via an implantable pump for spinal pain. It was reported that the caller reported that the patient had an MRI today (b)(4) and when they started the MRI, the patient felt a heat and warmth that started from the pump and went across. The caller stated the patient pushed the button and the pump was only off for about 15 minutes and then it restarted on its own. The caller confirmed the warmth had gone away and there were no other symptoms of burning or pain, just that the pump was slightly warm to touch over top of it. The caller asked if this was normal. The caller also stated during imaging that the pump was not completely flat on the patient body but not 90 degree towards the axis. The agent reviewed MRI labeling and pump location with caller.

  Patient problems: Burning Sensation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936863 ↗
• MalfunctionSep 29, 2026Charging Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936032 ↗
• MalfunctionSep 29, 2026Failure to Power Up; Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934058 ↗
• MalfunctionSep 29, 2026Application Program Freezes or Fails to Launch

  Information was received from a consumer regarding a patient with an implantable pump containing unknown drug for non-malignant pain. It was reported that their pump doesn't seem to be responding to their commands. Patient stated that when they are trying to initiate a bolus, the controller starts the procedure but everything loads real slow. Patient added that it goes up to 90% and then just sits there and does nothing. Agent reviewed with the patient that they need to clear the data in the device. Agent educated and assisted patient on how clear data in device. Patient was able to successfully connect to the pump without a lag.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927069 ↗
• InjurySep 28, 2026Disconnection; Migration or Expulsion of Device; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924058 ↗
• MalfunctionSep 28, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50919794 ↗
• InjurySep 25, 2026Insufficient Flow or Under Infusion

  Patient problems: Pain

  MAUDE report 50902609 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50899766 ↗
• MalfunctionSep 25, 2026Battery Problem

  Information was received from a patient regarding an external device to an implantable pump infusing hydromorphone, bupivacaine, and fentanyl for non-malignant pain. It was reported that their communicator was not holding a charge very long. Patient stated they just charged it yesterday and it was already down to 44%. Patient stated this had been going on for about 2 weeks now. A request was sent to the repair department.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898617 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from multiple sources (Manufacturer Representative, Healthcare Provider) regarding a patient who was receiv ing Unknown Drug via an implantable pump for unknown indications for use. It was reported that there was concerns for infection at the pump pocket site, so the patient's pump and catheter were both explanted on 2026-Sep-14. No manufacturer representative (rep) was present during the explant. There were no known environmental, external, or patient factors that may have led or contributed to this issue. It was unknown if any diagnostics or troubleshooting took place. The issue was resolved at the time of the report.

  Patient problems: Unspecified Infection

  MAUDE report 50885671 ↗
• MalfunctionSep 24, 2026Communication or Transmission Problem

  On 2026-SEP-11, information was received from a patient receiving an unknown drug via an implantable pump. It was reported the patient did not like their new pump controller as it took 5 minutes to provide a bolus.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883287 ↗
• MalfunctionSep 23, 2026Charging Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876074 ↗
• MalfunctionSep 23, 2026Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873347 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a healthcare professional via company representative regarding a patient with an implantable pump containing Fentanyl (2500 mcg/mL at 120.1 mcg/day) and Clonidine (10 mcg/mL at 0.480 mcg/day). It was reported that cerebrospinal fluid (CSF) started accumulating in pump pocket a few days after replacement of pump and insertion of new 8780 catheter surgery on (b)(6) 2026. The old catheter remained implanted. Patient presented at surgeons office a several times and had pocket drained with the expectation that origin of leak would seal up/heal on it's own. Took patient in for surgery on (b)(6) 2026 and removed old catheter and placed sutures around openings where it appeared that CSF was leaking from intrathecal space.

  Patient problems: Cerebrospinal Fluid Leakage; Seroma

  MAUDE report 50871188 ↗
• MalfunctionSep 23, 2026Communication or Transmission Problem

  Information was received from a patient regarding an external device. It was reported that when they try to deliver bolus it stops at 90% for 30 seconds and then will just go to bolus has been delivered. Agent assisted patient to clear data. Patient was able to connect to myPTM much faster and was routed to their lockout screen. Agent reviewed information and best practices.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869973 ↗
• MalfunctionSep 23, 2026Application Program Freezes or Fails to Launch

  Information waSee s received from a patient with an implantable pump for spinal pain indications. It was reported that ever since they got the device, they were always stuck at 90% while attempting to connect to the pump and deliver a bolus. The agent reviewed information. The agent had the patient close all apps and assisted the patient with clearing the data. The agent had the patient connect to the app, and the patient confirmed they were able to connect faster this time. The agent reviewed best practices.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869958 ↗
• MalfunctionSep 22, 2026Application Program Problem; Communication or Transmission Problem; Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858993 ↗

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-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

…and 25 more.