SYNCHROMED™ III 8667-20 (UDI 00763000999414)Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00763000999414), received between Apr 22, 2026 and Sep 30, 2026 — classified as 32 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (14 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. 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 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950511 ↗
• InjurySep 29, 2026Obstruction of Flow

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

  MAUDE report 50935065 ↗
• InjurySep 29, 2026Insufficient Device Problem Information

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

  MAUDE report 50934711 ↗
• InjurySep 29, 2026Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  Patient problems: Seroma

  MAUDE report 50934456 ↗
• MalfunctionSep 29, 2026Improper or Incorrect Procedure or Method

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932748 ↗
• InjurySep 28, 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 Baclofen (2,000 mcg/mg at 100 mcg per day) via an implantable pump for unknown indications for use. It was reported that the patient had their pump replaced due to "symptoms occurring." There were no known environmental, external, or patient factors that may have led to or contributed to this issue. No diagnostics were performed. It was unknown if the issue was resolved.

  Patient problems: Insufficient Information

  MAUDE report 50914148 ↗
• MalfunctionSep 25, 2026Failure to Power Up; Communication or Transmission Problem; Insufficient Device Problem Information

  Information was received from a patient who was receiving Morphine via an implantable pump for non-malignant pain. It was reported they were finally able to get the communicator on after probably 100 attempts to get it to turn on even though it was fully charged. Then the communicator shut off. Since then, they had only been able to connect one time, so twice total. The patient charged the communicator all the way and would get the green light turned on when plugged into the wall, but when they pressed the power button, it did not turn on. They held the button, but that did not work. They could not give a bolus and had severe problems with everything. The issue was not resolved. A request was sent to the repair department to replace the communicator.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898299 ↗
• MalfunctionSep 25, 2026Application Program Problem; Application Program Freezes or Fails to Launch

  Information was received from a patient regarding an external device to an implantable pump infusing unknown drug for malignant pain. It was reported that the patient stated for the past couple of weeks when they tried to bolus the handset was frozen at 90% and they got service code 156. The agent reviewed data and assisted the patient in deleting data. The patient was able to connect to the pump with no lag. The patient would call back if they needed any further assistance.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897096 ↗
• InjurySep 23, 2026Infusion or Flow Problem

  Information was received from multiple sources (Manufacturer Representative, Healthcare Provider) regarding a patient who was receiv ing Unknown Baclofen via an implantable pump for intractable spasticity. It was reported that the patient was displaying withdrawal symptoms and a dye study was completed and failed. The physician decided to implant an entire new catheter which resolved the issue.

  Patient problems: Insufficient Information

  MAUDE report 50869091 ↗
• InjurySep 22, 2026Insufficient Device Problem Information

  Information was received from a healthcare provider (HCP) regarding a patient receiving morphine via an implantable infusion pump for non-malignant pain indications for use. It was reported that the patient's catheter was disrupted and was revised on (b)(6) 2026. A catheter revision with a pump pocket exploration was performed (b)(6) 2026. The issue was resolved and the patient has an implanted functioning pump and catheter at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858860 ↗
• MalfunctionSep 22, 2026Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem

  Information was received from a patient regarding an external device to an implantable pump infusing unknown drug for non-malignant pain. It was reported that the patient reported that she was having to reset it every day before she could request a bolus. The patient clarified that it was taking a long time to request a bolus. The technical support services (TSS) walked the patient through clearing handset data. The patient was able to connect to request a bolus.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854242 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a healthcare provider (HCP) via a manufacturer's representative (Rep) regarding a patient receiving Li oresal (500mcg/mL at 75mcg/day) via an implantable infusion pump for unknown indications for use. It was reported that the patient's pump and catheter were replaced due to a possible infection at the pocket site. Environmental, external, and patient factors that may have contributed to this event were unknown. Diagnostics were unknown. Part of the catheter spine segment remains in place, but is not in use. The issue was resolved at the time of the report.

  Patient problems: Unspecified Infection

  MAUDE report 50849847 ↗
• InjurySep 21, 2026Pumping Stopped

  Additional information was received from a healthcare provider via company representative who reported that the patient did not experience any symptoms in relation to the motor stalls. The pump was reported to be explanted on 2026-Sep-17 and was not replaced.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848868 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50846392 ↗
• InjurySep 18, 2026Insufficient Device Problem Information

  Information was received from a healthcare provider (HCP) via a manufacturer's representative (Rep). It was reported that the patient's catheter was partially explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820141 ↗
• InjurySep 16, 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 Dilaudid (hydromorphone) (2 mg/ml at 0.144 mg/day) and Clonidine (100 mcg/ml at 7.2 mcg/day) via an implantable pump. It was reported that the incision from the pump implant had not healed properly and the pump was now exposed. The pump was explanted and the catheter was tied off.

  Patient problems: Impaired Healing; Pocket Erosion

  MAUDE report 50787578 ↗
• MalfunctionSep 14, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765645 ↗
• InjurySep 14, 2026Insufficient Device Problem Information

  Patient problems: Abdominal Cramps; Vomiting; Weight Changes

  MAUDE report 50763590 ↗
• MalfunctionSep 11, 2026Application Program Problem; Communication or Transmission Problem; Protective Measures Problem

  Information was received from a patient's representative (con) regarding an external device to an implantable pump infusing unknown drug for spinal pain. It was reported that the phone and a communicator for the caller's mother's new pump (installed on (b)(6) 2026) were malfunctioning. The communicator turned off if the handset took a long time to pair, the pump application on the handset froze a lot, like 4- 5 times per use, and sometimes stayed running in the background of the handset even when the application was closed. The communicator only seemed to work when she pressed it hard against the pump in her belly. The communicator also only held a charge for 24 hours. This was all quite unsustainable. The caller requested a representative to look at and possibly replace her equipment. On 2026-08-21 (b)(6)(con): Additional information was received from the patient. It was reported that the patient was having problems with her communicator. The patient stated just said "connecting "and did not connect and kept searching. The patient stated she started it again and just stuck at 90%. The agent walked the patient through clearing data and the patient was able to connect immediately. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734388 ↗
• MalfunctionSep 10, 2026Filling Problem

  Additional information was received from a manufacturer representative (rep) stating that it was determined that there was air in the pump. The cause of this was the tech unscrewing the syringe before it was done filling and air got in. No specific actions or interventions were done to resolve the issue. The pump was implanted, and it was reported to be working great.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716610 ↗
• InjurySep 9, 2026Infusion or Flow Problem

  Patient problems: Malaise; Shaking/Tremors

  MAUDE report 50701587 ↗
• MalfunctionSep 9, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697779 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50697526 ↗
• MalfunctionSep 9, 2026Insufficient Flow or Under Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50694181 ↗
• MalfunctionSep 8, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676255 ↗

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-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-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

…and 25 more.