Evoke Closed-Loop Stimulator (CLS)Recalls & reported problems across all models
Saluda Medical Pty Limited · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 460
- Deaths reported
- 4
- Injuries reported
- 456
- Recalls
- 0
We found 4 models of Evoke Closed-Loop Stimulator (CLS) by Saluda Medical Pty Limited in the FDA's device registry (GUDID). Together they are named in 460 adverse event reports in the FDA's MAUDE database, received between Jun 5, 2023 and Sep 30, 2026 — classified as 4 deaths, 456 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (95 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Evoke Closed-Loop Stimulator (CLS) problems
Device problems
- Adverse Event Without Identified Device or Use Problem227
- Patient-Device Incompatibility95
- Inappropriate/Inadequate Shock/Stimulation59
- Lack of Effect42
- Migration22
- Charging Problem13
- Patient Device Interaction Problem13
- Failure to Charge12
Patient problems
- Unspecified Infection108
- Inadequate Pain Relief101
- Implant Pain95
- No Clinical Signs, Symptoms or Conditions53
- Impaired Healing31
- Undesired Nerve Stimulation26
- Post Operative Wound Infection19
- Purulent Discharge19
Evoke Closed-Loop Stimulator (CLS) models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Evoke® Closed-Loop Stimulator (CLS) 3042Stimulator, Spinal-Cord, Totally Implanted For Pain Relief322 reports
- Evoke® Closed-Loop Stimulator (CLS) 3002Stimulator, Spinal-Cord, Totally Implanted For Pain Relief2 deaths81 reports
- Evoke® Closed-Loop Stimulator (CLS) 3002Stimulator, Spinal-Cord, Totally Implanted For Pain Relief2 deaths56 reports
- Evoke® Closed-Loop Stimulator (CLS) 3042Stimulator, Spinal-Cord, Totally Implanted For Pain Relief1 report
Recent Evoke Closed-Loop Stimulator (CLS) adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Communication or Transmission Problem
A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System reported difficulty establishing connection between the Evoke Closed Loop Stimulator (CLS) and Evoke Charger, resulting in the inability to perform a soft reset and charge the CLS. Troubleshooting was performed, and an attempt to connect the Evoke CLS to the Evoke Clinical Interface was unsuccessful. The patient was without therapy. A revision procedure was performed, and the CLS was replaced to resolve the reported event.
Patient problems: Inadequate Pain Relief
MAUDE report 50945605 ↗InjurySep 30, 2026Communication or Transmission Problem
A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System reported difficulty establishing connection between the Evoke Closed Loop Stimulator (CLS) and Evoke Charger, resulting in the inability to perform a soft reset and charge the CLS. Troubleshooting was performed, and an attempt to connect the Evoke CLS to the Evoke Clinical Interface was unsuccessful. The patient was without therapy. A revision procedure was performed, and the CLS was replaced to resolve the reported event.
Patient problems: Inadequate Pain Relief
MAUDE report 50945596 ↗InjurySep 29, 2026Signal Artifact/Noise; Inappropriate/Inadequate Shock/Stimulation
A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System reported undesirable increase in stimulation while programming the Evoke Closed Loop Stimulator (CLS). The reported undesirable increase in stimulation occurred 2 weeks following a separate procedure in which electrocautery was used. It was suspected that the Evoke CLS may have been damaged due to electrocautery usage during the previous procedure. An explant procedure was performed to resolve the reported event.
Patient problems: Undesired Nerve Stimulation
MAUDE report 50935547 ↗InjurySep 29, 2026Signal Artifact/Noise; Inappropriate/Inadequate Shock/Stimulation
Patient problems: Undesired Nerve Stimulation
MAUDE report 50935546 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System was evaluated for wound dehiscence at the Evoke Closed Loop Stimulator (CLS) implant site. The patient did not report pain; however, the physician elected to explant the Evoke SCS System. The physician plans to re-implant the patient in three months. The Evoke SCS System was functioning as intended prior to the explant.
Patient problems: Wound Dehiscence
MAUDE report 50855679 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System was evaluated for wound dehiscence at the Evoke Closed Loop Stimulator (CLS) implant site. The patient did not report pain; however, the physician elected to explant the Evoke SCS System. The physician plans to re-implant the patient in three months. The Evoke SCS System was functioning as intended prior to the explant.
Patient problems: Wound Dehiscence
MAUDE report 50855678 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System was evaluated in the emergency room for a possible infection. The physician¿s evaluation confirmed the patient had an idiopathic infection. The Evoke SCS System was explanted and medication was administered to resolve the reported event. The Evoke SCS System was confirmed to be functioning as intended prior to the explant.
Patient problems: Unspecified Infection
MAUDE report 50842693 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System was evaluated in the emergency room for a possible infection. The physician¿s evaluation confirmed the patient had an idiopathic infection. The Evoke SCS System was explanted and medication was administered to resolve the reported event. The Evoke SCS System was confirmed to be functioning as intended prior to the explant.
Patient problems: Unspecified Infection
MAUDE report 50842690 ↗InjurySep 21, 2026Patient Device Interaction Problem
A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System requested a system explant due to inadequate pain relief and disliking the stimulation sensation. The patient additionally reported that they were experiencing phantom leg pain and the pain would increase during stimulation. During the patient¿s trial period and following the permanent implantation, the patient reported that adequate pain relief was achieved. The Evoke SCS System was explanted to resolve the reported event.
Patient problems: Pain
MAUDE report 50842412 ↗InjurySep 21, 2026Patient Device Interaction Problem
A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System requested a system explant due to inadequate pain relief and disliking the stimulation sensation. The patient additionally reported that they were experiencing phantom leg pain and the pain would increase during stimulation. During the patient¿s trial period and following the permanent implantation, the patient reported that adequate pain relief was achieved. The Evoke SCS System was explanted to resolve the reported event.
Patient problems: Pain
MAUDE report 50842410 ↗InjurySep 17, 2026Patient-Device Incompatibility
Patient problems: Implant Pain
MAUDE report 50811583 ↗InjurySep 17, 2026Patient-Device Incompatibility
Patient problems: Implant Pain
MAUDE report 50811582 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50807263 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System was evaluated for an infection at the Evoke Closed Loop Stimulator (CLS) implant site. The physician¿s opinion was that the Evoke SCS System did not cause or contribute to the infection. An explant procedure was performed, and medication was administered to resolve the reported event. The Evoke SCS System was confirmed to be functioning as intended prior to the explant.
Patient problems: Unspecified Infection
MAUDE report 50807259 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System was evaluated for a systolic blood pressure below 100. No signs or symptoms of an infection were identified during evaluation; however, the physician suspected a possible infection related to the Evoke SCS System. No additional intervention was performed due to absence of signs or symptoms of infection.
Patient problems: Low Blood Pressure/ Hypotension; Unspecified Infection
MAUDE report 50753365 ↗
Other Saluda Medical Pty Limited products
All Saluda Medical Pty Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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