SYNCHROMEDIIRecalls & reported problems across all models

We found 4 models of SYNCHROMEDII by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 3,289 adverse event reports in the FDA's MAUDE database, received between Aug 10, 2018 and Sep 30, 2026 — classified as 6 deaths, 2,099 injuries, 1,184 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (465 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

SYNCHROMEDII recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-0615-2024 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

2. 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 · names 2 of these models · Recall details · FDA record ↗

Most reported SYNCHROMEDII problems

SYNCHROMEDII models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SYNCHROMED®II 8637-20

  Pump, infusion, implanted, programmable
  1 recall2 deaths1,646 reports
• SYNCHROMED®II 8637-40

  Pump, infusion, implanted, programmable
  1 recall3 deaths1,478 reports
• SYNCHROMED®II 8637-40

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall1 death94 reports
• SYNCHROMED®II 8637-20

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall71 reports

Recent SYNCHROMEDII adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952157 ↗
• InjurySep 30, 2026Insufficient Flow or Under Infusion

  Patient problems: Pain

  MAUDE report 50948157 ↗
• MalfunctionSep 30, 2026Electromagnetic Interference

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946733 ↗
• InjurySep 29, 2026Obstruction of Flow; Insufficient Device Problem Information

  Patient problems: Scar Tissue

  MAUDE report 50941289 ↗
• MalfunctionSep 29, 2026Charging Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939799 ↗
• InjurySep 24, 2026Insufficient Flow or Under Infusion; Insufficient Device Problem Information

  Information was received from a patient (pt) regarding an implantable infusion pump. The reason for call was Pt reported the pump was alarming because the pump is empty and the alarm was waking them at night. Pt stated that they were having trouble with the pain clinic because the pump is not working for 5 months, they met a rep at the hospital and was told the pump was working properly, they did a CT scan and showed the catheter is in the right place. Pt is asking if the nurse can put a 'Saline' in the pump. Pt said they had fentanyl and went through serious withdrawal. Agent reviewed information and redirected pt to their HCP to further address the issue. When asked for HCP information, pt said they found another doctor affiliated to the hospital, but they couldn't see them until they got the medical records for at least another week.

  Patient problems: Insufficient Information

  MAUDE report 50885246 ↗
• MalfunctionSep 24, 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 patient reported that they got the 8835 PTM replaced about a month ago (b)(6) and then about a week after that (b)(6), the patient stated that it 'doesn't connect very easily' and they had difficulty connecting and finding the right spot for quite a long time and stopped at 91%. The patient denied falls/trauma but - stated they had surgery on their hip on the opposite side of the pump (unrelated) and they had difficulty connecting before the surgery as well. The agent reviewed information and assisted the patient with clearing data from the handset. The patient stated they were then able to connect to the pump quicker. The patient mentioned that were allowed 13 boluses a day. The patient would monitor issue and call back if further assistance was needed. *** See PE 709291017 regarding 8835 PTM replacement ***

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883066 ↗
• MalfunctionSep 23, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873581 ↗
• MalfunctionSep 23, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868120 ↗
• InjurySep 22, 2026Insufficient Flow or Under Infusion; Insufficient Device Problem Information

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

  MAUDE report 50859774 ↗
• MalfunctionSep 22, 2026Communication or Transmission Problem

  Information was received from a patient who was receiving Dilaudid (hydromorphone) via an implantable pump for non-malignant pain. It was reported that over the last couple of months, then stated "about 1.5 to 2 months," the handset had been lagging at 90% for sometimes up to 15-20 minutes when they are trying to bolus. They stated sometimes they had to wait so long they were not sure if they even got the bolus.  The agent reviewed Data and assisted the patient in deleting the data. The patient was able to connect to the pump with no lag.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857866 ↗
• MalfunctionSep 21, 2026Electromagnetic Interference

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848017 ↗
• MalfunctionSep 21, 2026Improper or Incorrect Procedure or Method

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846204 ↗
• InjurySep 21, 2026Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  Additional information was received from the healthcare provider (HCP) via the manufacturer representative (rep). Patient and pump information were provided. It was reported that the cause of the drug entry issue was user error. The rep stated they would have the patient go into the office to make adjustments. Resolution of the issue was in the process. The patient had an office visit scheduled for (b)(6) 2026.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840917 ↗
• InjurySep 18, 2026Migration or Expulsion of Device; Insufficient Device Problem Information

  Patient problems: Cerebrospinal Fluid Leakage; Cyst(s); Headache; Pain

  MAUDE report 50824708 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls