SYNCHROMED® II 8637-40 (UDI 00643169630512)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,929 adverse event reports that list this exact device (DI 00643169630512), received between Oct 3, 2018 and Sep 30, 2026 — classified as 7 deaths, 3,327 injuries, 1,595 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (829 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Nov 13, 2023Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 4,929 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 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 ↗
• MalfunctionSep 29, 2026Insufficient Flow or Under Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939239 ↗
• 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 ↗
• MalfunctionSep 28, 2026Insufficient Flow or Under Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916586 ↗
• MalfunctionSep 28, 2026Electromagnetic Interference

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914299 ↗
• MalfunctionSep 25, 2026Application Program Freezes or Fails to Launch

  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 getting stuck at 90% for quite a while this year, probably all year. An agent assisted the patient with clearing data on the handset and the patient was able to connect to the pump. The troubleshooting steps that were taken on the call resolved the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900377 ↗
• MalfunctionSep 25, 2026Human-Device Interface Problem; Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899164 ↗
• InjurySep 24, 2026Disconnection; Material Integrity Problem; Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50886235 ↗
• MalfunctionSep 24, 2026Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876599 ↗
• MalfunctionSep 23, 2026Fluid/Blood Leak

  Information was received from a healthcare provider (hcp) via a manufacturing representative (rep) regarding a patient who was receiving Baclofen (unknown concentration, unknown dosage) via an implantable pump for unknown indication. It was reported that the during pump replacement, when the CAP was being aspirated and flushed, the proximal pump segment was leaking where the catheter attached to the pump. The physician decided to replace the pump segment at that time. The physician was asked if he wanted to ship the old pump segment for evaluation. The physician declined and the old pump segment was discharged. The issue was resolved at the time of the report. The healthcare provider (hcp) had no further information for the manufacturer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871827 ↗
• MalfunctionSep 22, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862807 ↗
• MalfunctionSep 22, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858990 ↗
• InjurySep 22, 2026Filling Problem; Device Ingredient or Reagent Problem; Infusion or Flow Problem; Insufficient Device Problem Information

  Information was received from a manufacturer representative, patient, and healthcare provider regarding the patient who was receiving Unknown Baclofen via an implantable pump for intractable spasticity indications for use. It was reported that the physician called the manufacturer representative (rep) to discuss a problem during the patients' refill. Caller stated that the patient had reported increased spasms and spasticity and the pump was not working like it normally would. Caller stated that the physician did not say when this onset. Caller stated that the healthcare provider (HCP) went to fill the pump and they were able to aspirate a drop from the reservoir but were only able to insert 30mL. Caller stated that they were going to meet with the HCP and patient today, and they were going to take an x-ray of the pump. Caller stated that they will be referring the patient to the surgeon since the patient is due for a pump replacement soon and are not getting the same therapeutic efficacy. Additional information was later received from the rep. They added that the HCP aspirated 40mL from the reservoir, and filled it with 40mL. Caller stated that the physician accessed the Catheter

  Patient problems: Cramp(s) /Muscle Spasm(s); Muscular Rigidity; Pain

  MAUDE report 50857761 ↗
• MalfunctionSep 22, 2026Electromagnetic Interference

  Information was received from the healthcare provider (HCP) regarding a patient receiving intrathecal Hydromorphone via an implantable pump for non-malignant pain. The HCP reported service codes 99 "[pump stopped]" and 100 "[pump motor stalled]" when interrogating the pump and that pump had been stalled for 384 hrs. Patient had recently had an Magnetic Resonance Imaging (MRI). Agent advised the HCP to check logs; logs showed motor stall recovery occurred today. Troubleshooting done on the call resolved the reported issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857481 ↗
• InjurySep 21, 2026Obstruction of Flow; Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 50843090 ↗
• InjurySep 21, 2026Filling Problem; Insufficient Flow or Under Infusion; Insufficient Device Problem Information

  Information was received from a patient who was receiving Unknown Morphine Drug and Clonidine via an implantable pump for spinal pain indications for use. It was reported that the patient (pt) had morphine and clonidine. With the morphine, they were beginning to itch really bad. Pt expressed concern that the pump was not functioning properly and that they were not receiving the medication as intended. Pt asked if the itching could be a side effect of the morphine. Pt mentioned that they had researched online and found that both morphine and clonidine could potentially cause itching. When asked about the event date, pt stated they were having more problems when the pump was replaced. Pt mentioned during their refill on (b)(6)2026, the healthcare provider (HCP) removed the existing medication and refilled the pump with new medication. Pt further stated that "35 cc was withdrawn from the pump and left 5 cc, so for few months I wasn't getting any medication, except 5% and that was very low for me." Agent reviewed information and redirected pt to the HCP. Pt stated that they already told their doctor during their refill, and they were advised that morphine was not the side effect of the

  Patient problems: Insufficient Information; Itching Sensation

  MAUDE report 50839228 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a patient who was receiving Dilaudid (hydromorphone) via an implantable pump for non-malignant pain. It was reported that the patient stated that the pump was expiring and as of now they were going through withdrawals and they were having a hard time trying to find a provider that would replace the pump. The patient said that they were dealing with another condition so they kept getting denied to have the pump replaced. The patient said that the pump had been alarming for almost for 2 months now and they were sick from withdrawals. The patient said that they had been in and out of the hospital already. The patient said that the physician only refilled pumps and did not replace pumps. The patient said that Health Care Provider (HCP) sent them back to the surgeon, however the surgeon wasn't willing to replace the pump due to an issue with the patient's platelets. The patient said that another HCP could raise their platelets, but the surgeon wasn't willing to replace the pump. Agent offered to e-mail the patient a physician Listing via e-mail/the patient accepted. Additional information was received from the healthcare provider (HCP) stating that the caus

  Patient problems: Insufficient Information; Malaise; Thrombosis/Thrombus

  MAUDE report 50819551 ↗
• MalfunctionSep 17, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804623 ↗
• InjurySep 17, 2026Infusion or Flow Problem

  Information was received from the healthcare provider (HCP) via the company representative (rep) regarding a patient receiving intrathecal medication via an implantable pump. It was reported that they did imaging and had a negative side port. They did not have flow so they replaced the whole thing. The issue resolved at the time of this report. There were no symptoms.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801957 ↗
• InjurySep 16, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794615 ↗
• MalfunctionSep 16, 2026Communication or Transmission Problem

  Information was received from the patient receiving intrathecal medication via an implantable pump for non-malignant pain and DEGEN Disc Disease/Herniated Disc pain. The patient was experiencing a lag at 90% while attempting to bolus. Agent educated and assisted patient on how clear data in device. Patient was able to successfully connect to the pump without a lag.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789873 ↗
• InjurySep 14, 2026Infusion or Flow Problem; Material Integrity Problem

  Patient problems: Pain

  MAUDE report 50765547 ↗
• InjurySep 14, 2026Migration or Expulsion of Device

  Information was received from the healthcare provider via a clinical study regarding a patient receiving Baclofen and Hydromorphone via an implantable infusion pump. It was reported that during a scheduled pump replacement secondary to normal battery depletion, it was observed that the catheter tip had migrated from T6 to T5. The catheter was replaced ,positioning the new catheter at T6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752107 ↗

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-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-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-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-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.