SYNCHROMED® II 8637-20 (UDI 00763000634094)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,242 adverse event reports that list this exact device (DI 00763000634094), received between Sep 14, 2022 and Sep 30, 2026 — classified as 3 deaths, 1,215 injuries, 1,024 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (487 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. Nov 13, 2023Open, Classified

   Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling.

   Z-0614-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,242 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Electromagnetic Interference; Insufficient Device Problem Information

  Patient problems: Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Diaphoresis; Insufficient Information; Malaise; Pain

  MAUDE report 50950141 ↗
• InjurySep 29, 2026Electromagnetic Interference; Pumping Stopped

  Patient problems: Pain

  MAUDE report 50940883 ↗
• InjurySep 29, 2026Insufficient Flow or Under Infusion

  Information was received from a patient receiving Dilaudid via an implantable infusion pump for spinal pain indications. It was reported that for the past 3 years, every 4th of July, their pump 'runs dry for a whole week' and the patient goes through withdrawals.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50936662 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cognitive Changes; Pain

  MAUDE report 50934611 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6)2026, information was received from a Manufacturer Representative (REP), regarding a patient receiving baclofen (2,000 mcg /ml, 529.5 mcg/day) via an implantable pump. It was reported that the patient reported to the emergency department with symptoms of baclofen withdrawal. There were no known environmental, external, or patient factors that may have led or contributed to the issue. The diagnostics / troubleshooting performed was the catheter was aspirated through the side port. The full system was replaced as an intervention. It was unknown if the issue was resolved at the time of this report.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50918083 ↗
• MalfunctionSep 28, 2026Failure to Power Up; Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915515 ↗
• InjurySep 25, 2026Migration or Expulsion of Device; Insufficient Flow or Under Infusion; Obstruction of Flow; Infusion or Flow Problem

  Patient problems: Pain

  MAUDE report 50902981 ↗
• MalfunctionSep 25, 2026Display or Visual Feedback Problem; Charging Problem

  Information was received from a consumer regarding a patient with an implantable pump containing unknown drug for non-malignant pain. It was reported that the patient's communicator was not charging, They patient (pt) contacted their doctor but was told to call patient services. Pt said the issue started about 6 months ago. Pt already tried to use different charger and outlet, but the communicator still won't charge. Pt confirmed no visible damage on the port of the communicator. When they powered on the communicator, they got the blue flashing light but no orange light on the battery indicator when plugged in to the charging cord. Pt stated that the same charging cord that they were using for the handset and communicator was working to their other device. Troubleshooting steps taken on the call didn't resolve the issue. Agent sent a request to replace the communicator.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898556 ↗
• MalfunctionSep 25, 2026Application Program Freezes or Fails to Launch

  Information was received from a patient, receiving an unknown drug via an implantable infusion pump for non-malignant pain indications for use. It was reported that the patient's handset was lagging at 90% and it was taking about 10 minutes to deliver a bolus. The patient mentioned that they had met the manufacturer's representative (Rep) at the doctor's office and were instructed to call patient services. When asked for event date, the patient stated that the issue has been ongoing for a while since they had the pump. The Agent reviewed information and walked the patient through clearing the data. The patient was able to connect to the pump with no lag. The patient mentioned that they just delivered a bolus before they called. The Agent reviewed best practices and instructed the patient to call back if they needed further assistance.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897315 ↗
• MalfunctionSep 23, 2026Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876305 ↗
• InjurySep 23, 2026Insufficient Flow or Under Infusion; Obstruction of Flow; Infusion or Flow Problem

  Patient problems: Insufficient Information

  MAUDE report 50874024 ↗
• MalfunctionSep 22, 2026Failure to Power Up; Charging Problem; Communication or Transmission Problem; Protective Measures Problem

  Information was received from the patient receiving intrathecal Morphine (unknown) via an implantable pump for spinal pain indications. The patient reported that the communicator would not charge and now it was dead. Patient said she uses it every day several times a day and needed it by tomorrow. Agent asked what happens when patient attempts a bolus and patient said they get a message to deliver bolus but could not. Patient also said the charging port was broken and they could not get the cord to go in. Patient tried a new cord and that did not resolve the issue. The issue was not resolved through troubleshooting. A request was sent to the repair department. Patient called back stating they still did not get their new equipment and they had had several hours without pain medicine now.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858201 ↗
• MalfunctionSep 18, 2026Data Problem

  Additional information was received from the manufacturing representative (rep). The rep reported that the cause of the non-critical pump memory error was not determined. No actions were taken to resolve the issue. There were results to provide regarding diagnosti cs or troubleshooting. It was just the patient reporting that they saw an error. The issue was resolved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828920 ↗
• InjurySep 17, 2026Migration or Expulsion of Device

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Shaking/Tremors

  MAUDE report 50812653 ↗
• InjurySep 17, 2026Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50811501 ↗
• InjurySep 16, 2026Insufficient Device Problem Information

  Information was received from a patient's representative regarding an external device to an implantable pump infusing unknown drug and unknown Morphine for non-malignant pain. It was reported that the patient stated they had back surgery on Thursday ((b)(6) 2026).The historical event reported. The patient stated that last Thursday ((b)(6) 2026), they had to have a catheter revision. The patient also stated they had to have the "tubing rerouted".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792018 ↗
• MalfunctionSep 15, 2026Failure to Power Up; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775367 ↗
• MalfunctionSep 14, 2026Failure to Power Up; Charging Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763383 ↗
• MalfunctionSep 14, 2026Communication or Transmission Problem

  Information was received from the patient receiving intrathecal Dilaudid (hydromorphone) via an implantable pump for non-malignant pain. It was reported that for the past 2 months or maybe more the patient had been having issues with their handset. Patient stated that the handset was getting stuck at 90% when it was loading and they had to wait 2 minutes and 13 seconds for the handset to respond to the request for a bolus. During the call the patient service specialist walked the patient through clearing data services and connecting to the pump. Patient was able to successfully connect and request/receive a bolus. Agent reviewed proper communicator positioning. Patient would monitor the issue and call back if needed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755819 ↗
• MalfunctionSep 14, 2026Failure to Power Up; Insufficient Device Problem Information

  Information was received from the patient receiving intrathecal medication via an implantable pump for non-malignant pain. The patient reported that for the past couple of weeks the communicator would not work consistently. The patient stated it would just cut off while she was trying to get a bolus. The patient stated now the communicator would not come on and it would not respond to the charging cord. Patient did try different charging cords but that did not resolve the issue. See request to repair for the communicator.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754644 ↗
• MalfunctionSep 14, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752895 ↗
• MalfunctionSep 11, 2026Failure to Power Up; Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735177 ↗
• MalfunctionSep 10, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713808 ↗
• MalfunctionSep 9, 2026Electromagnetic Interference

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697870 ↗
• MalfunctionSep 9, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50694164 ↗

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-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.