SYNCHROMED™ III 8667-40 (UDI 00763000999421)Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00763000999421), received between Apr 13, 2026 and Sep 30, 2026 — classified as 20 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (10 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Migration or Expulsion of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950562 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Fluid Discharge

  MAUDE report 50950549 ↗
• InjurySep 29, 2026Infusion or Flow Problem

  Patient problems: Insufficient Information

  MAUDE report 50937241 ↗
• MalfunctionSep 28, 2026Application Program Freezes or Fails to Launch

  Information was received from a patient regarding an external device to an implantable pump infusing unknown Baclofen for intractable spasticity. It was reported that the past couple nights ((b)(6) 2026) the patient had been trying to bolus and the controller kept saying 0% and did not do anything. The patient stated they turned the controller off and back on again and it acted like it gave them a bolus but they could not tell if it gave the bolus or not. The agent walked the patient through clearing the data. The patient was able to connect and then see the bolus screen.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921028 ↗
• MalfunctionSep 24, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885544 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from multiple sources (Healthcare Provider, Clinical Study) regarding a patient who was receiving Bupivacaine and Fentanyl via an implantable pump. It was reported that per physical exam, mild erythema was present around pump wound. Clindamycin 300mg 3x/day was administered. During visit on (b)(6) 2026 as well as (b)(6) 2026: per physical exam revealed that mild erythema had improved significantly with second course of Clindamycin. Medihoney was administered. Per physical exam on (b)(6) 2026, small scabs and mild erythema were present.

  Patient problems: Erythema; Post Operative Wound Infection; Scar Tissue

  MAUDE report 50884491 ↗
• MalfunctionSep 24, 2026Communication or Transmission Problem

  Information was received from a patient (pt) who was receiving Unknown Drug via an implantable pump for malignant pain indications for use. It was reported that the patient had a 5 min delay when trying to bolus for an unknown amount of time. Pt did say that they have cleared the handset data once before. Technical Services walked the pt through clearing the handset data and pt was able to connect to the pump without delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882725 ↗
• MalfunctionSep 23, 2026Communication or Transmission 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 handset was lagging at 90% for the past couple of days ((b)(6) 2026). The agent reviewed and guided the patient through clearing the data. The patient was then able to connect to the pump without any lag. The agent emailed lag instructions.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872377 ↗
• MalfunctionSep 23, 2026Communication or Transmission Problem

  Information was received from a friend/family member regarding a patient who was receiving Unknown Morphine Drug via an implantable pump for non-malignant pain. It was reported that the patient fell this morning and landed face first and hit their stomach, but it was mainly their face. Caller stated that when they got back from the ER, they were going to dispense the pump, but they were getting no device found. Caller confirmed that the communicator and handset were charged, and they restarted the handset and unplugged and plugged it back in, but that did not resolve the issue. Agent walked caller through resetting the handset. Caller was able to successfully connect to the pump after restarting the handset, but reported seeing No Device Found. The issue was not resolved through troubleshooting. The patient was redirected to their healthcare provider to further address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870047 ↗
• InjurySep 18, 2026Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: Loss of consciousness; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828367 ↗
• MalfunctionSep 17, 2026Communication or Transmission Problem

  Information was received from a friend/family member regarding a patient with an implantable pump for non-malignant pain. It was reported that when the patient tried to bolus, it was taking a long time and lagged at 90 percent. The agent reviewed information and assisted the patient with clearing data. The patient was able to connect to the pump without issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806711 ↗
• InjurySep 17, 2026Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Improper Flow or Infusion; Infusion or Flow Problem

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805487 ↗
• MalfunctionSep 14, 2026Obstruction of Flow; Infusion or Flow Problem

  Additional information was received from the manufacturing representative (rep). The rep confirmed that the reported implant volume was .213mL. The cause of the inability to get a full 1-2cc's was reported by the physician to be that something was blocking the catheter. They confirmed that it was cleared after flushing it with saline. It was asked but unknown if the patient's therapy resumed as expected.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763348 ↗
• MalfunctionSep 14, 2026Filling Problem; Migration or Expulsion of Device; Device Ingredient or Reagent Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756554 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from multiple sources (Manufacturer Representative, Healthcare Provider) regarding a patient who was receiving Gablofen (2000 mcg/ml at 689.5 mcg/day) via an implantable pump for unknown indications for use. It was reported that the patient had their pump replaced on (b)(6) 2026 and then presented on (b)(6) 2026 with withdrawal symptoms. No factors were noted. No actions or interventions have been done at the time of the report, but the patient's healthcare provider (HCP) was planning on giving a bolus of medication if symptoms didn't improve. It was unknown if the issue resolved. Additional information was received from a manufacturer representative (rep) on 2026-Aug-31 stating the cause of the withdrawal symptoms was unknown. The specific symptoms the patient experienced were also unknown. Rep was unaware of any additional actions or interventions to resolve the symptoms. It was still unknown if this issue has resolved. Additional information was received from the healthcare provider (HCP) on 2026-Sep-01. When asked about specific symptoms the patient experience, the cause of the withdrawal symptoms, the actions/interventions taken to resolve the withdraw

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cramp(s) /Muscle Spasm(s); Itching Sensation; Muscular Rigidity

  MAUDE report 50693041 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a patient receiving an unknown drug via an implantable infusion pump for intractable spasticity. It was reported that the patient wanted to meet with a manufacturer's representative (Rep) to check their pump for possible leaks because they were experiencing an overdose. The patient stated they had consulted with their healthcare provider (HCP) about this issue, but the HCP stated there was no issue with the pump. The patient mentioned that they experienced overdose three days after implantation. The patient stated they tried reducing the dose three times, but nothing improved. The patient commented that they have had this device for over 20 years and 'know when there is an issue with it'. The patient was unsure whether the drug was Lioresal or Gablofen. The patient was redirected to their HCP for further assistance.

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

  MAUDE report 50692259 ↗
• MalfunctionSep 8, 2026Insufficient Flow or Under Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50679551 ↗
• InjurySep 8, 2026Insufficient Flow or Under Infusion; Infusion or Flow Problem

  Information was received from multiple sources (Healthcare Provider, Clinical Study) regarding a patient who was receiving Dilaudid (hydromorphone), Bupivacaine, and Fentanyl via an implantable pump. It was reported that the catheter was unable to be aspirated during pump replacement surgery. On (B)(6 )2026 the nurse expected 5mL and pulled 34mL, patient reported she did not feel her boluses and had increased heart rate, nausea, and vomiting following pump replacement. A catheter dye study was forgone and a catheter revision would be performed.

  Patient problems: Nausea; Tachycardia; Vomiting

  MAUDE report 50675414 ↗
• MalfunctionSep 2, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50573539 ↗
• MalfunctionSep 1, 2026No Audible Alarm; Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550134 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a healthcare provider regarding a patient who was receiving Bupivacaine and Dilaudid (hydromorphone) via an implantable pump for malignant pain and other indications for use. It was reported that they are going to be shutting off the pump permanently, and they were wondering what the code was. Caller stated that the patient started experiencing side effects right away after implant and a possible infection in the cervical area. Caller stated that they "don't feel like it's the pump" that is the issue. Agent provided code to shut down pump.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50519331 ↗
• InjuryAug 24, 2026Migration or Expulsion of Device; Material Integrity Problem

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

  MAUDE report 50420812 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50354413 ↗
• MalfunctionAug 17, 2026Application Program Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287155 ↗
• MalfunctionAug 17, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286721 ↗

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-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.