SYNCHROMED®II 8637-40 (UDI 00763000422615)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,478 adverse event reports that list this exact device (DI 00763000422615), received between Jul 15, 2021 and Sep 30, 2026 — classified as 3 deaths, 988 injuries, 487 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (236 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,478 reports, 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 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 ↗
• InjurySep 18, 2026Insufficient Flow or Under Infusion; Obstruction of Flow

  Information was received from a patient via a manufacturing representative (rep) who was receiving Fentanyl (2000 MCG/ML at 96.2 MCG /DAY) via an implantable pump for malignant pain and head/neck (non-malignant). It was reported that the patient came in for a while system pump replacement. In pre-op, the patient informed the rep that they felt a difference in their pain when they weaned them down on their dosing. They also stated that the doses had not been helping as much as when they first had it implanted. The discrepancy reports of the latest refills ranged from 5-10 mL more in the pump than had been expected. The healthcare provider (HCP) was able to aspirate easily off the pump, however upon x-ray with dye intra-op, they saw a kink in the catheter. They decided to replace the catheter and the pump. The issue was resolved at the time of the report.

  Patient problems: Pain

  MAUDE report 50820028 ↗
• InjurySep 18, 2026Infusion or Flow Problem

  Information was received from the patient via the company representative (Rep) regarding a patient receiving intrathecal Morphine 2 mg/ml at 0.2 mg /day via an implantable pump. It was reported that the patient felt like he was not getting the therapy/relief that he used to get. It was mentioned they were having more back pain than usual. Patient stated that there were no falls. The physician decided decide to do a catheter aspiration. He was not getting any flow back from the catheter access port (CAP) on the pump. Physician decided to do a catheter replacement. It was reported that the issue had resolved at the time of this report.

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

  MAUDE report 50817135 ↗
• InjurySep 16, 2026Pumping Stopped

  Patient problems: Convulsion/Seizure; Muscular Rigidity

  MAUDE report 50793191 ↗
• MalfunctionSep 15, 2026Filling Problem; Insufficient Flow or Under Infusion

  2026-Sep-14 Clinical (b)(4) (hcp, sdy): Information was received from multiple sources (Healthcare Provider, Clinical Study) regarding a patient who was receiving Bupivacaine, Fentanyl, and Dilaudid (hydromorphone) via an implantable pump. It was reported that the pump registered nurse was unable to push in 1.5mL. During a refill on 2026-Sep-10 they were expecting 4.5mL but pulled out 14mL. The patient denied change in pain or withdrawal symptoms.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774985 ↗
• InjurySep 14, 2026Improper Flow or Infusion; Infusion or Flow Problem; Material Integrity Problem

  Information was received from multiple sources (Manufacturer Representative, Healthcare Provider) regarding a patient who was receiv ing Dilaudid (hydromorphone) via an implantable pump for unknown indications for use. It was reported that for the last several months she has had increased pain. She also states that at her last three routine pump refill visits she had volume discrepancies. She is unable to provide the exact expected/actual volumes, nor does she remember the exact dates. She states that she also had a dose increase that she did not notice any benefit from. On (b)(6) 2026, she had a catheter access study performed by the managing provider which she reports was negative. Patient denies any falls, recent surgeries, or other precipitating factors. Patient was taken to the OR today for a planned catheter revision. The physician began by opening up the existing pump pocket and dissecting down to the existing pump and proximal segment. He attempted to aspirate from the catheter access port, but had no return of CSF. He then cut approximately 10 cm off of the proximal segment, and attempted to aspirate directly from the remaining catheter, but still had no return of CSF. At

  Patient problems: Pain

  MAUDE report 50758016 ↗
• InjurySep 14, 2026Insufficient Device Problem Information

  Information was received from a patient representative regarding a patient with an implantable pump containing Baclofen (Unknown) for intractable spasticity. It was reported that the patient representative went to visit the patient yesterday and heard the pump alarm going off. Caller stated it was more than a single beep she was hearing. Caller said they called the nursing home and asked if the patient was getting at least oral baclofen and they were told no. Caller also said the pain management doctor sent the patient to the doctor's and they said the patient did not need the pump filled anymore. It was not known why this was the case. Caller did not know when the refill was scheduled for but stated that that was the reason why it was alarming. Caller stated she believed the patient was going through withdrawals based on her state yesterday. Caller mentioned they were always told when the patient lived with them that if the alarm went off that was considered a medical emergency and they had to take the patient a couple different times when that did happen and it didn't usually happen because they made the patient go to the doctor to get it filled all the time. Caller stated the ne

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

  MAUDE report 50755189 ↗
• MalfunctionSep 14, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754278 ↗
• MalfunctionSep 11, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735792 ↗
• InjuryAug 27, 2026Filling Problem; Material Integrity Problem; Positioning Problem

  Information was received from multiple sources (Manufacturer Representative, Healthcare Provider) regarding a patient who was receiving Dilaudid (hydromorphone) (7.5 mg/mL at 4.1017 mg/day) and Bupivacaine (5 mg/mL at 2.7345 mg/day) via an implantable pump for unknown indications for use. It was reported that the patient's pump was sitting in the abdomen in an oblique position which made refills challenging. Additionally, the catheter tip was found at T8 based on previous imaging, so the healthcare provider (HCP) was planning to pull the catheter down through the pump pocket to T10 to see if it would provide the patient (pt) better pain relief. The pt was taken to the operating room today for a planned pocket revision. The HCP began by opening up the pump pocket and dissecting down to the existing pump and proximal segment. The HCP removed the existing pump from the pocket and placed it on the sterile table. After disconnecting the pump, the HCP proceeded to dissect out the full length of the proximal segment. HCP then disconnected the proximal segment from the spinal segment at the collet. They noted cerebrospinal fluid (CSF) freely dripping from the spinal segment. Under fluorosc

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50483249 ↗
• InjuryAug 26, 2026Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50461926 ↗
• MalfunctionAug 18, 2026Display or Visual Feedback Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50303429 ↗
• MalfunctionAug 17, 2026Electromagnetic Interference

  Information was received from a consumer via a manufacturer representative regarding a patient who was receiving Fentanyl via an imp lantable pump for spinal pain indications. They had an MRI on Sunday around 3pm, and the pump stalled. The caller stated that the pump was interrogated sometime last night and did not show the stall recovery message. The caller said they were heading over to read the pump once again today. The agent reviewed information about the potential for permanent motor stall and telemetry mode. The caller was not with the patient at the time of the call, so further troubleshooting could not be performed. The issue was not resolved through troubleshooting. The patient was redirected to their healthcare provider (HCP) to further address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50281058 ↗
• MalfunctionAug 12, 2026Charging Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50226838 ↗
• InjuryAug 3, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50123986 ↗
• InjuryJul 29, 2026Improper Flow or Infusion; Adverse Event Without Identified Device or Use Problem

  Information was received from a healthcare provider via company representative regarding a patient with an implantable pump containing Morphine (unknown) (3500 MCG/ML at 1500 mcg/day). It was reported that the physician had discrepancy's while doing refills. A due study was performed to see if the issue was with the catheter was aspirated and no issues were found. It was reported that a new pump was implanted. It was not known if the  event had resolved at the time of this report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50069234 ↗
• InjuryJul 29, 2026Infusion or Flow Problem

  Information was received from a healthcare provider via company representative regarding a patient with an implantable pump containing Compounded Baclofen (900 mcg/ml at 300 mcg/mo). It was reported that the patient experienced a loss of therapy. It was not known if there were any environmental/external/patient factors that may have led or contributed. It was reported that the 8780 catheter was explanted and replaced with a new 8780. Additional information was received from a healthcare provider via company representative stating that the cause of the patient's lack of therapy was not known. It was noted that during the replacement there was no flow from the catheter. There were no obvious cause for flow disruption discovered. After replacement of a new catheter that resolved the issue.

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

  MAUDE report 50069194 ↗
• InjuryJul 29, 2026Insufficient Device Problem Information

  Information was received from a friend/family member regarding a patient who was receiving Dilaudid (hydromorphone) and Unknown Baclofen via an implantable pump for intractable spasticity. It was reported that patient was admitted to the hospital last night after the pain doctor adjusted the pump yesterday. Caller stated patient's blood pressure reached 200/100 and could not be lowered. Caller also stated patient had never received a bolus before, and the bolus had worked fine before the pump adjustment. Caller reported the doctor was unsure how to manage the pump and called Patient and Technical Services to ask whom to contact to interrogate the device in person, with concern that the pump might be malfunctioning. Agent redirected caller to healthcare provider (HCP).

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 50067985 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from the patient via the company representative (Rep) regarding a patient receiving intrathecal medication via an implantable pump. The patient's pump system implanted in 2022 was explanted a month after it was implanted due to infection. Additional information provided by the company representative (Rep) reported that this issue had resolved.

  Patient problems: Unspecified Infection

  MAUDE report 50067367 ↗
• MalfunctionJul 28, 2026Communication or Transmission Problem

  Additional information was received from the patient. The patient reported that they had the connection lag issue. 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 50056599 ↗
• MalfunctionJul 28, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50052928 ↗

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-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-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-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.