SYNCHROMED®II 8637-20 (UDI 00763000422608)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,646 adverse event reports that list this exact device (DI 00763000422608), received between Jul 6, 2021 and Sep 30, 2026 — classified as 2 deaths, 993 injuries, 651 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (241 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-0614-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,646 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• MalfunctionSep 17, 2026No Audible Alarm; Insufficient Flow or Under Infusion; Adverse Event Without Identified Device or Use Problem

  Information was received from a patient who was receiving Unknown Morphine Drug and Unknown Baclofen via an implantable pump for CANCER CHEMOTHERAPY and LUMBAR RADICULOPATHY. It was reported that  the patient (pt) is in need of a refill that's not scheduled. Pt states he is out of town and has to get to AZ. Pt wondered if there was any beeping that should take place. Agent reviewed types of alarms. Pt states he got a notification last night that the refill was due for today. Pt states saw service code 97. Pt states says expected refill (b)(6)2206. Pt states on his paperwork shows (b)(6) for the dates of both pumps. Pt states he doesnt have any issues currently and wondered if people will hear the alarm if starts on the plane and if he can fly ok with the alarm if it starts alarming. Agent reviewed and directed to hcp. Pt mentioned its always been that way where they have to removed more medication out, pt states theres always some left over and wondered if there was an extra layer. Pt did not know when that all started. Pt s tates he is going to have the pump filled next week.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804070 ↗
• MalfunctionSep 17, 2026No Audible Alarm; Insufficient Flow or Under Infusion; Adverse Event Without Identified Device or Use Problem

  Information was received from a patient who was receiving Unknown Morphine Drug and Unknown Baclofen via an implantable pump for CANCER CHEMOTHERAPY and LUMBAR RADICULOPATHY. It was reported that  the patient (pt) is in need of a refill that's not scheduled. Pt states he is out of town and has to get to AZ. Pt wondered if there was any beeping that should take place. Agent reviewed types of alarms. Pt states he got a notification last night that the refill was due for today. Pt states saw service code 97. Pt states says expected refill (b)(6) 2206. Pt states on his paperwork shows Sept 03 and the 08 for the dates of both pumps. Pt states he doesnt have any issues currently and wondered if people will hear the alarm if starts on the plane and if he can fly ok with the alarm if it starts alarming. Agent reviewed and directed to hcp. Pt mentioned its always been that way where they have to removed more medication out, pt states there's always some left over and wondered if there was an extra layer. Pt did not know when that all started. Pt states he is going to have the pump filled next week.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804035 ↗
• MalfunctionSep 16, 2026Electromagnetic Interference

  Additional information was received from the healthcare provider (HCP) via the company representative (rep) reporting that they went up with the office to rescan the pump just after getting off of the phone with technical services. When they reinterrogated the pump and checked the logs the motor had recovered. The recovery was on September 2nd and it showed up on the logs as soon as we reinterrogated right after hanging up with technical services. The office scanned the pump with their tablet so the company rep did not have access to the report, but pain management clinic had the report as they were the ones that interrogated the tablet both times.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793726 ↗
• MalfunctionSep 16, 2026Charging Problem; Communication 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 the communicator was not charging. The patient mentioned that the top piece of the charging cord was indented some and they had to bend it one way to get it to charge. The issue was not resolved through troubleshooting. A request was sent to repair to replace the communicator for a damaged port.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790231 ↗
• InjurySep 16, 2026Insufficient Flow or Under Infusion; Insufficient Device Problem Information

  Information was received from multiple sources (Patient, Manufacturer Representative, Healthcare Provider) regarding a patient who was receiving Fentanyl (6.0 MG/ML at 4.4 MG/DAY) via an implantable pump for non-malignant pain indications for use. It was reported that thought the letter they received (see related event (b)(4)) was referring to their "pump failure" and the fact that they were not responding to the medication. Patient stated the therapy issue started "several months ago." Patient stated the healthcare provider (HCP) had done a catheter dye study and they couldn't tell where the medication was going. Patient stated the HCP planned a catheter revision. Additional information was received via a HCP through a manufacturer representative (rep) stating that they were concerned for possible underdose. There were no known external factors. The patient had their pump and catheter replaced. The issue was noted to be resolved.

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

  MAUDE report 50788483 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a healthcare provider (HCP) regarding a patient who was receiving Dilaudid (hydromorphone) and Clonidine via an implantable pump for spinal pain indications. It was reported that there was an infection at the spine site that started in May or June. The caller stated that the patient received 6 weeks of IV antibiotics, and the infection returned, so they were removing the pump.

  Patient problems: Unspecified Infection

  MAUDE report 50778659 ↗
• MalfunctionSep 14, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765425 ↗
• MalfunctionSep 8, 2026Charging Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50677718 ↗
• MalfunctionSep 8, 2026Communication or Transmission Problem

  Information was received from a consumer regarding a patient with an implantable pump containing unknown drug for spinal pain. It was reported that it takes a long time to deliver boluses. Agent educated and assisted patient on how clear data in device. Patient was able to successfully connect to the pump without a lag. "[See PE (b)(4) for error codes]".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668872 ↗
• MalfunctionSep 8, 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 was experiencing a lag at 90% while attempting to bolus. An agent educated and assisted the patient on how clear data in the device. The patient was able to successfully connect to the pump without a lag. See PE (b)(4) for omitted information regarding lag issue with previous handset.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668778 ↗
• InjurySep 2, 2026Adverse 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 50576246 ↗
• MalfunctionSep 2, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566849 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a patient with an implantable pump for intractable spasticity. It was reported that they had spastic diplegia cerebral palsy. They stated on (b)(6) morning they woke up and could not move anything but their fingers. They contacted their pump management nurse did not hear anything from them until the afternoon. The patient ended up collapsing on the floor into a full body spasm. The patient had noticed 2-3 days later there was severe discoloration around the pump area and the area was raised. The patient verified they had not had any issues prior with any of the pump refills or getting medication through the pump. They mentioned that the pump was replaced in 2022, but this time it felt totally different. They believed the pump nurse they saw today told them that they were not due for a refill until maybe next month at this time. The patient was redirected to their healthcare provider (HCP) to further address the issue. They stated they would have an appointment to see the HCP for a dye study on Wednesday this week, but they did not think they could wait that long.

  Patient problems: Cramp(s) /Muscle Spasm(s); Insufficient Information; Skin Discoloration; Swelling/ Edema

  MAUDE report 50531549 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a patient receiving Unknown morphine via an implantable infusion pump for non-malignant pain. It was reported that the patient was supposed to have their pump filled in (b)(6) 2026, but because they owed money for the last refill, their healthcare provider (HCP) would not fill the pump. The patient stated they had been in severe pain and had to be hospitalized twice due to the pain and going through withdrawals. The Agent emailed physician listings as requested by the patient.

  Patient problems: Pain

  MAUDE report 50487477 ↗
• MalfunctionAug 27, 2026Insufficient Device Problem Information

  Information was received from a patient who was receiving Baclofen via an implantable pump for spinal pain indications. It was reported that they would have an appointment to see the doctor who fills their pump with baclofen at 10:30 on August 20th. They mentioned they had been told that the baclofen was not reaching their spine and was just circulating. They stated the doctor would shut the pump off, and would probably remove the pump as it was not doing anything. The agent redirected them to the healthcare provider (HCP) to further address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50485257 ↗

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-0615-2024 · Nov 13, 2023 · Open, Classified
  Medtronic SynchroMed II, Model 8637-40, 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-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-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-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.