SYNCHROMED IIRecalls & reported problems across all models
Medtronic, Inc. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one SYNCHROMED II model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 32,260
- Deaths reported
- 52
- Injuries reported
- 20,968
- Recalls
- 4
We found 11 models of SYNCHROMED II by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 32,260 adverse event reports in the FDA's MAUDE database, received between Apr 23, 2014 and Sep 30, 2026 — classified as 52 deaths, 20,968 injuries, 11,240 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (4,125 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 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
Reports received per month, all models
SYNCHROMED II 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.
- Sep 11, 2024Open, Classified
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
Z-0137-2025 · Root cause: Device Design · Recall details · FDA record ↗
- 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 5 of these models · Recall details · FDA record ↗
- 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 5 of these models · Recall details · FDA record ↗
- Aug 9, 2017Open, Classified
Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design that are not implanted.
Z-0896-2018 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
Most reported SYNCHROMED II problems
Device problems
- Adverse Event Without Identified Device or Use Problem8,677
- Infusion or Flow Problem4,125
- Insufficient Flow or Under Infusion3,775
- Insufficient Device Problem Information3,454
- Migration or Expulsion of Device3,329
- Material Integrity Problem2,892
- Pumping Stopped2,879
- Obstruction of Flow2,075
Patient problems
- No Clinical Signs, Symptoms or Conditions8,220
- No Known Impact Or Consequence To Patient6,354
- Pain5,650
- Therapeutic Response, Decreased3,253
- Unspecified Infection2,439
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2,396
- Muscular Rigidity1,674
- Insufficient Information1,624
SYNCHROMED II models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SYNCHROMED® II 8637-40PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall7 deaths4,929 reports
- SYNCHROMED® II 8637-20PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls5 deaths4,303 reports
- SYNCHROMED ® II 8637-40PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall6 deaths4,119 reports
- SYNCHROMED® II 8637-40PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls10 deaths3,054 reports
- SYNCHROMED ® II 8637-20PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall4 deaths3,084 reports
- SYNCHROMED® II 8637-20PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls1 death2,588 reports
- SynchroMed® II 8637-40PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall6 deaths2,291 reports
- SYNCHROMED® II 8637-20Pump, infusion, implanted, programmable1 recall3 deaths2,242 reports
- SYNCHROMED® II 8637-40Pump, infusion, implanted, programmable1 recall4 deaths1,964 reports
- SynchroMed® II 8637-20PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall4 deaths1,920 reports
- SYNCHROMED ® II 8637-20PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 deaths1,766 reports
Recent SYNCHROMED II adverse event reports
The 15 most recent reports across all models, 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 50954050 ↗InjurySep 30, 2026Insufficient Device Problem Information
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50951548 ↗MalfunctionSep 30, 2026Application Program Problem; Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951259 ↗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 30, 2026Insufficient Device Problem Information
Patient problems: Burning Sensation; High Blood Pressure/ Hypertension; Pain
MAUDE report 50946737 ↗InjurySep 29, 2026Electromagnetic Interference; Pumping Stopped
Patient problems: Pain
MAUDE report 50940883 ↗MalfunctionSep 29, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939239 ↗MalfunctionSep 29, 2026Device Alarm System; Electromagnetic Interference; Pumping Stopped; Vibration; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
Additional information was received from the manufacturer representative (rep) stating the cause of the motor stall was because of a Magnetic Resonance Imaging (MRI). The low reservoir alarm happened simultaneously. The alarms were silenced and the issue is resolved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938283 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
Patient problems: Bacterial Infection; Device Embedded In Tissue or Plaque
MAUDE report 50937164 ↗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 ↗MalfunctionSep 29, 2026Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934021 ↗InjurySep 29, 2026Infusion or Flow Problem
Information was received from a a healthcare provider (HCP) via a manufacturer representative (rep) regarding a patient who was receiving Morphine (20mg/ml at 6.2 mg/day simple continuous. Max daily dose of 7.4 mg with) via an implantable pump for non-malignant pain. It was reported that they were unable to aspirate the catheter. No were no reported contributing factors. The catheter was revised with a new spinal segment. The issue was resolved at the time of the report. The HCP had no additional information for the manufacturer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933420 ↗InjurySep 28, 2026Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem
Patient problems: Ambulation or Postural Difficulties; Cramp(s) /Muscle Spasm(s); Discomfort; Itching Sensation; Muscular Rigidity
MAUDE report 50925988 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50923366 ↗
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
- 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
- Medtronic Azure Pacemaker12 models · 16,566 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page