SYNCHROMED® II 8637-40 (UDI 00763000634100)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,964 adverse event reports that list this exact device (DI 00763000634100), received between Aug 3, 2022 and Sep 28, 2026 — classified as 4 deaths, 1,172 injuries, 788 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (368 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 1,964 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjurySep 28, 2026Infusion or Flow Problem

  Information was received from multiple sources (Manufacturer Representative, Healthcare Provider) regarding a patient who was receiv ing Fentanyl and Unknown Morphine Drug via an implantable pump for spinal pain indications. It was reported that they made a medication change and they were about half way through the bridge bolus. Today they intended to clear out all the medication by aspirating through the CAP but they were only able to get a small amount of medication and were not able to clear the catheter. Caller then stated that patient became narcotized just after the procedure. Caller said that they reversed it with a little Narcan but they would like to pause the bridge boluses. Agent reviewed with the caller that they could program the pump to minimum rate mode and resume therapy when they want then complete a modified bridge bolus for the remained of the old drug. Caller stated that the original bolus was 42H and 44min and he is getting ready to stop it now at 22h and 6 min remaining. The healthcare provider (HCP) will call back for further assistance when they decide to turn the pump back. The physician called back stating that they will be restarting the pump.

  Patient problems: Insufficient Information

  MAUDE report 50921456 ↗
• InjurySep 25, 2026Fluid/Blood Leak; Infusion or Flow Problem

  Information was received from the healthcare provider (HCP) via the company representative (rep) regarding a patient receiving intrathecal Baclofen (Gablofen) 500 mcg/ml at 50 mcg/day via an implantable pump. It was reported that per the managing clinic, the patient developed unexpected withdrawal symptoms during normal use. Per the managing clinic, the patient experienced a fall (date unknown) prior to experiencing withdrawal symptoms. A catheter dye study was attempted (date unknown), but per the managing clinic the catheter could not be aspirated. The existing catheter was found to be leaking at or near the collet between the pump and spinal segments. A catheter revision was scheduled to troubleshoot the implanted system and revise if necessary. Upon opening the pocket, free fluid was observed around the pump. The surgeon then aspirated the catheter via the catheter access port of the old pump and 3mL of clear fluid was withdrawn. However, the surgeon also noticed a clear fluid welling up around the collet between the spinal and pump segments and opted to revise the catheter with a new 8784 revision kit. The pump was also replaced prophylactically, but no complaints were made re

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

  MAUDE report 50896472 ↗
• InjurySep 24, 2026Insufficient Flow or Under Infusion

  Information was received from a consumer regarding a patient with an implantable pump previously containing Baclofen (Unknown), Bupivacaine, and another unknown drug for spinal pain indications. It was reported that the patient thought they could find a new provider before the pump ran out but they stated they were wrong. Patient mentioned back in January they saw someone locally at a new pain management clinic and the doctor told them that because they don't have any experience with intrathecal baclofen, they needed to find someone else to wean them down off the baclofen, so they could take over their care. Patient was very excited about this prospect but they could not find anyone to ween them off of the back of the pump so they have completely gone off all of their intrathecal and oral opioids and have no intrathecal medication left. Patient went to a new primary care provider at their old primary care doctor's office to discuss going forward and the provider wanted to put the patient in a suboxone clinic and patient was already through withdrawal and that seemed like a bad idea to them so their primary care physician kicked them out of the practice for noncompliance. Agent revi

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

  MAUDE report 50886469 ↗
• InjurySep 24, 2026Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information; Muscle Weakness/Atrophy; No Clinical Signs, Symptoms or Conditions; Numbness

  MAUDE report 50886334 ↗
• MalfunctionSep 24, 2026Communication or Transmission Problem; Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885859 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Additional information was received from a healthcare provider (HCP). It was reported that the device/therapy was not causal or contributory with respect to the ICU (intensive care unit) stay for breakthrough seizures. The pump was interrogated. The patient recovered. The patient had a history of seizure disorder treated with levetiracetam. The pump was on and delivering therapy as expected.

  Patient problems: Convulsion/Seizure

  MAUDE report 50872494 ↗
• InjurySep 22, 2026Pumping Stopped

  Information was received from multiple sources (Manufacturer Representative, Healthcare Provider) regarding a patient who was receiv ing Bupivacaine (10 mg/mL at 14.393 mg/day) and Unknown Morphine Drug (15 mg/mL at 14.393 mg/day) via an implantable pump for non-malignant pain indications for use. It was reported that the patient had a refill on (b)(6)2026. Caller stated the pump was at 5.6ml when patient came in for the refill, and it was filled to 40%. Caller verified the pump was not alarming when pt was in for refill. Caller stated that today, the patient contacted their pain office and said the pump was alarming every 10 minutes since this morning. Patient does not have a controller/Personal Therapy Manager. Patient stated they did not have any external devices near the pump area over the past 2 days that could have produced electromagnetic interference. Patient was unsure when the pump started to alarm, but they noticed it this morning. Patient reported they were in more pain last night but when they tried to ask more about their pain, the patient said they are always in pain. Patient also said they had diarrhea this morning which was not normal for them. The issue was not re

  Patient problems: Diarrhea; Pain

  MAUDE report 50857650 ↗
• InjurySep 21, 2026Insufficient Flow or Under Infusion; Infusion or Flow Problem

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50848574 ↗
• InjurySep 21, 2026Premature Elective Replacement Indicator

  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 the patient noticed no difference in therapy effectiveness and the patient had good pain relief still from therapy. Providers noticed at last few refills that the elective replacement indicator (ERI) date was decreasing at a ¿rapid rate.¿ The company rep was working with clinic to get documentation of this. No diagnostics were completed. The doctor felt most comfortable with replacing the device due to the ERI date decreasing quickly. The issue resolved at the time of this report with a new pump implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842050 ↗
• InjurySep 21, 2026Material Integrity Problem

  Information was received from multiple sources (Manufacturer Representative, Healthcare Provider) regarding a patient who was receiv ing Dilaudid (hydromorphone) (15 mg/mL at 0.104 mg/day) and Bupivacaine (10 mg/mL at 0.069 mg/day) via an implantable pump for spinal pain indications. It was reported that a segment of the patient¿s previous 8780 catheter was cut, removed and discarded during a prior spinal fusion procedure. The length of the discarded segment is unknown. During the current catheter revision, the physician elected to replace only the spinal segment and estimated the length of the remaining catheter based on available measurements rather than replacing the entire catheter as recommended. The calculated catheter length of 108.8 cm was therefore not definitively confirmed. As a result, the exact length of the remaining catheter could not be established during the current revision. The patient was initially placed on minimum rate because the programmed drug concentration would otherwise have resulted in a higher initial dose. The new catheter was not primed because the patient had not been receiving medication prior to the revision. During the catheter revision procedure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841581 ↗
• MalfunctionSep 18, 2026Charging Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50824948 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50822890 ↗
• MalfunctionSep 18, 2026Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50821950 ↗
• InjurySep 18, 2026Migration or Expulsion of Device; Insufficient Flow or Under Infusion; Excessive Heating

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bruise/Contusion; Dizziness; Foreign Body Reaction; Insufficient Information; Nausea; Wound Dehiscence

  MAUDE report 50821009 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50811062 ↗
• MalfunctionSep 17, 2026Charging Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809923 ↗
• InjurySep 16, 2026Migration or Expulsion of Device; Obstruction of Flow

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

  MAUDE report 50796786 ↗
• InjurySep 16, 2026Infusion or Flow Problem

  Patient problems: Insufficient Information

  MAUDE report 50794712 ↗
• InjurySep 16, 2026Excess Flow or Over-Infusion; Infusion or Flow Problem

  Information was received from a patient who was receiving Dilaudid (hydromorphone) via an implantable pump for non-malignant pain. It was reported that in (b)(6) they had a pump refill, and they had an opioid crisis after the refill. They stated within 15 minutes, they felt like they had IV of Morphine. The patient stated the managing healthcare provider (HCP) did an audit, and there was medication missing. They then stated at the next refill, which was (b)(6), they had another opioid crisis but not as bad as (b)(6). They mentioned they tried to do a dye study, and they could not get anything from the catheter withdrawn so they could inject the dye. The agent reviewed information. The patient was redirected to their healthcare provider to further address the issue.

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

  MAUDE report 50789861 ↗
• MalfunctionSep 16, 2026Communication or Transmission Problem

  Information was received from a patient, receiving Unknown drug via an implantable infusion pump for non-malignant pain, regarding an external device. It was reported that, for 'quite a while', the patient had been having issues with their handset. The patient stated the handset would do 2-3 things and give them options of restarting the app or waiting. The patient also stated the screen would go black and when it did that, it shuts it all off and they had to restart it. The patient mentioned it was taking up to an hour and a half to 2 hours to get a bolus when it used to take 10-15 minutes. The Agent walked the patient through closing out of all running applications and clearing the data in the device. The patient was able to successfully connect to the pump and see their lockout time. The troubleshooting steps taken on the call resolved the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788314 ↗
• InjurySep 15, 2026Electromagnetic Interference

  Information was received from a patient who was receiving Bupivacaine via an implantable pump for intractable spasticity. It was reported that the pump malfunctioned the last time they had an MRI approximately two years ago and the caller stated the patient ended up in the ICU 2 weeks afterwards and they don't know if it did not come back on and the patient ended up in a serious withdraw or if they overdosed on it.

  Patient problems: Insufficient Information

  MAUDE report 50772212 ↗
• MalfunctionSep 14, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765060 ↗
• MalfunctionSep 14, 2026Improper or Incorrect Procedure or Method

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762994 ↗

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.