SYNCHROMED® II 8637-20 (UDI 00643169630505)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,303 adverse event reports that list this exact device (DI 00643169630505), received between Sep 21, 2018 and Sep 30, 2026 — classified as 5 deaths, 2,686 injuries, 1,612 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (643 reports).

2 FDA recall records name this device's identifier, 2 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. Sep 11, 2024Class IIOpen, 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 ↗

2. 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-0614-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 4,303 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Insufficient Device Problem Information

  Patient problems: Burning Sensation; High Blood Pressure/ Hypertension; Pain

  MAUDE report 50946737 ↗
• 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 ↗
• MalfunctionSep 29, 2026Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934021 ↗
• InjurySep 28, 2026Insufficient Device Problem Information

  Patient problems: Convulsion/Seizure

  MAUDE report 50920080 ↗
• MalfunctionSep 25, 2026Communication or Transmission Problem

  Information was received from the patient receiving intrathecal Dilaudid (hydromorphone) via an implantable pump for spinal pain. The patient reported "since about 2 weeks after patient received the pump" when they would bolus, the handset would lag at 91%. Patient stated after they would have a pump fill, it would connect faster and then gradually would start taking longer to connect. Agent reviewed Data and assisted patient in deleting the data and patient was able to connect to the pump with no lag. Patient would call back if they need further assistance.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900077 ↗
• MalfunctionSep 25, 2026Communication or Transmission Problem

  Information was received from a patient who was receiving Fentanyl via an implantable pump for non-malignant pain indications for use. It was reported that for the past couple weeks, the patient had issues with their controller. Patient stated that the controller was slow to log in and they were not able to receive their boluses. Agent walked patient through clearing the data. The troubleshooting steps that were taken on the call resolved the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896960 ↗
• MalfunctionSep 23, 2026Communication or Transmission Problem

  Information was received from a friend/family member regarding a patient who was receiving Bupivacaine and Fentanyl via an implantable pump for spinal pain. It was reported that the communicator port was damaged. The issue was not resolved through troubleshooting. A request was sent to the repair department to replace the Communicator.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872768 ↗
• MalfunctionSep 23, 2026Application Program Freezes or Fails to Launch

  Information was received from a patient regarding an external device to an implantable pump infusing unknown morphine for non-malignant pain. It was reported that the patient stated that it took a long time to connect the handset to the pump because it was getting stuck at 90%. An agent assisted the patient with deleting the data, and after that, the patient was able to connect to the pump without any lag. However, the patient remained adamant about replacing the handset as the healthcare provider (HCP) suspected that the handset might have an issue. The agent reviewed the information and sent a repair request to replace the handset. Additional information was later received from the patient, who confirmed they had been experiencing the 90% lag. The patient did not have the handset with them to conduct the troubleshooting the agent offered.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871210 ↗
• InjurySep 22, 2026Environmental Compatibility Problem; Insufficient Device Problem Information

  Information was received from a patient with an implantable pump for non-malignant pain. It was reported that they had been having a problem with their house with the electric. They stated that on July 16th, almost a year from the time the healthcare provider (HCP) put the new pump in, something popped in it.  The patient mentioned that the old battery started doing it just before they took it out. The patient also mentioned that when they moved their trailer, they didn't ground it down, so the whole floor was shocking them. They did not know that was what it was for years, since 2020, and the old pump finally gave out but they were being shocked then too.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857771 ↗
• MalfunctionSep 21, 2026Communication or Transmission Problem; Insufficient Device Problem Information

  Information was received from a patient who was receiving Clonidine, Bupivacaine, and Dilaudid (hydromorphone) via an implantable pump for non-malignant pain indications for use. It was reported that the communicator port and charging cord had melted. Patient stated the plastic on both sides was damaged, and the connection appeared burnt and dark. Patient added they were about to perform a bolus but noticed the communicator and charging cord had melted. Agent sent a request to repair to replace the communicator and charging cord. Additional information was received when the patient received their replacement communicator. The patient noted that there were no instructions included. Agent attempted to walk patient through pairing communicator. Patient reported Not Found Communicator and tapped Switch Communicator. Patient reported Searching, Ensure the Communicator is powered on and then No Device Found with blue screen and the option to Retry. Patient confirmed communicator was powered on and not plugged in and toggled Bluetooth off and back on; patient confirmed location was on. Patient again attempted to pair and reported same screens. Patient restarted handset and reset communica

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840935 ↗
• MalfunctionSep 18, 2026Filling Problem; Migration or Expulsion of Device

  Patient problems: Ambulation or Postural Difficulties; Incontinence; Insufficient Information; Pain; Swelling/ Edema; Weight Changes

  MAUDE report 50826164 ↗
• MalfunctionSep 16, 2026Insufficient Flow or Under Infusion

  Information was received from a manufacturer representative (rep) regarding a patient receiving Dilaudid, bupivacaine, and unknown b aclofen via an implantable pump for spinal pain. It was reported that the patient had been getting some residual volumes. The patient had a side port study in February which was normal. The rep stated they were able to pull fluid and they were wondering about the flow rate. The rep asked what amount of residual volume they should be worried about since the staff was getting 1.9 cc's, 2.3 cc's and 2.5, and asked when they should be questioning the integrity of the pump and the catheter. The rep said that today they aspirated 2.8ml more than expected and this was the largest volume discrepancy yet. An agent reviewed flow rate specifications. The rep stated the patient fell recently and possibly injured their left hip, so it was hard to tease out if the pain the patient was having was the pump under delivering medication or if it was the fall. The rep said they suspected it was more the fall and the patient had not reported a dramatic pain increase other than the fall. The rep also mentioned the patient's ERI (elective removal indicator) was a year and a

  Patient problems: Pain

  MAUDE report 50793080 ↗
• InjurySep 16, 2026Insufficient Device Problem Information

  Information was received from a company representative regarding a patient with an implantable pump containing Morphine (unknown) for non-malignant pain. It was reported that the patient's last revision was in (b)(6) of 2020 which was like 2 or 3 months after, and the patient verified it. The healthcare provider at the time of the revisions was unknown but the patient stated it was done in (b)(6). It was also reported that during a normal pump replacement on (b)(6)2026, the company representative wondered if during the previous revision the healthcare provider had to splice it or something because they couldn't put the catheter in normally. Additional information was received from a company representative stating that it was not known if there was a known device issue as the catheter revision was completed in a different state. It was reported that a replacement had happened but no update was provided to manufacturer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788066 ↗
• MalfunctionSep 15, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782258 ↗
• MalfunctionSep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778007 ↗
• MalfunctionSep 14, 2026Improper Flow or Infusion; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765178 ↗
• InjurySep 10, 2026Insufficient Device Problem Information

  Information was received from a patient regarding an external device to an implantable pump infusing Hydromorphone and Bupivacaine for non-malignant pain. The patient mentioned historical information that with their old pump before it was replaced it got to a point where the fentanyl in the pump was degrading the pump. *** Information omitted and split into PE 709344637 ****

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714674 ↗
• InjurySep 9, 2026Insufficient Flow or Under Infusion; Insufficient Device Problem Information

  Information was received from a patient who was receiving Unknown Morphine Drug via an implantable pump for non-malignant pain indications for use. It was reported that the patient (pt) was having issues where the pump was not dispensing like it should be, and they have been experiencing pain because of it. Agent reviewed if the Patient Telemetry Module (PTM) indicated the bolus was successful then the external equipment was working as intended. Patient stated they were alerted to this issue when their healthcare provider (HCP) pulled out "a lot of morphine" when the patient was getting the patch and the HCP stated "only30-40 percent was used" even thought the patient only missed 2-3 boluses. Patient stated this has been occurring for a while 6-9 months. Agent redirected patient to their HCP to discuss therapy and volume discrepancy concerns. Patient mentioned they were approaching replacement time. Agent reviewed longevity.

  Patient problems: Pain

  MAUDE report 50691758 ↗
• MalfunctionSep 8, 2026Battery Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50678929 ↗
• MalfunctionSep 4, 2026Charging Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50622865 ↗
• MalfunctionSep 3, 2026Positioning Problem

  Additional information was received from the manufacturing representative (rep). The rep reported that the device was replaced on (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50594397 ↗
• MalfunctionSep 2, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50573884 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information

  MAUDE report 50573841 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Scar Tissue

  MAUDE report 50523173 ↗
• MalfunctionAug 28, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50498195 ↗

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-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.