SHOCKPULSERecalls & reported problems across all models
Gyrus ACMI, LLC · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
5 open recalls name at least one SHOCKPULSE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 580
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 5
We found 11 models of SHOCKPULSE by Gyrus ACMI, LLC in the FDA's device registry (GUDID). Together they are named in 580 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2020 and Sep 29, 2026 — classified as 8 injuries, 572 malfunctions.
The most frequently reported specific device problem is “Break” (104 reports).
5 FDA recall records name at least one of these models by its device identifier, 5 still open.
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
SHOCKPULSE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 8, 2026Open, Classified
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.
Z-1494-2026 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
- Nov 14, 2025Open, Classified
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Z-1479-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Nov 14, 2025Open, Classified
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Z-1478-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Nov 14, 2025Open, Classified
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Z-1477-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Jul 7, 2022Open, Classified
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment
Z-1514-2022 · Root cause: Process change control · Recall details · FDA record ↗
Most reported SHOCKPULSE problems
Device problems
- Break104
- Output Problem56
- Communication or Transmission Problem52
- Activation Problem36
- No Device Output31
- Energy Output Problem28
- Connection Problem27
- Failure to Power Up27
Patient problems
- No Clinical Signs, Symptoms or Conditions545
- No Patient Involvement22
- Insufficient Information7
- No Consequences Or Impact To Patient4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Fistula1
- Hemorrhage/Blood Loss/Bleeding1
- Pneumothorax1
SHOCKPULSE models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ShockPulse SPL-TLithotriptor, ultrasonic279 reports
- ShockPulse SPL-SLithotriptor, ultrasonic2 recalls159 reports
- SHOCKPULSE SPL-SRLithotriptor, Ultrasonic2 recalls97 reports
- ShockPulse SPL-GLithotriptor, ultrasonic2 recalls10 reports
- ShockPulse SPL-FSLithotriptor, ultrasonic20 reports
- SHOCKPULSE SPL-PDBX340Lithotriptor, Ultrasonic4 reports
- SHOCKPULSE SPL-PDBX376Lithotriptor, Ultrasonic4 reports
- SHOCKPULSE SPL-PR150Lithotriptor, Ultrasonic3 reports
- SHOCKPULSE SPL-PDBX150Lithotriptor, Ultrasonic2 reports
- SHOCKPULSE SPL-PR340Lithotriptor, Ultrasonic1 report
- SHOCKPULSE SPL-PDBX183Lithotriptor, Ultrasonic1 report
Recent SHOCKPULSE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Output below Specifications
It was reported that the shock pulse lithotripsy system exhibited poor power output. The issue occurred during a therapeutic procedure that was delayed for less than 30 minutes under sedation. The procedure was subsequently completed using the same device. No reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935175 ↗MalfunctionSep 28, 2026Unexpected Shutdown
It was reported that during an unspecified therapeutic procedure, the lithotripsy transducer stopped working during the procedure. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916680 ↗MalfunctionSep 25, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903647 ↗MalfunctionSep 22, 2026Activation Problem
The customer returned the LITHOTRIPSY SYSTEM to the service center for a separate issue. During the device analysis, the investigator indicated that a failed probe test due to faulty control board was found. It was determined that the control board needed to be replaced. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854807 ↗MalfunctionSep 21, 2026Connection Problem
During onsite inspection of the Lithotripsy, it was found Transducer plug is not secured. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847416 ↗MalfunctionSep 16, 2026Failure to Deliver Energy
It was reported that, while using the shockpulse lithotripsy transducer, the shockpulse was not working. Onsite inspection results identified no output from the shockpulse. The issue occurred during set-up/inspection for use. There was no report of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790692 ↗MalfunctionSep 15, 2026Communication or Transmission Problem
It was reported the Lithotripsy gave continuous check probe error. The issue occurred during inspection for use. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50770947 ↗MalfunctionSep 14, 2026Failure to Deliver Energy; Activation Failure
It was reported the Lithotripsy was not producing ultrasonic energy. The issue occurred during Percutaneous nephrolithotomy (PCNL) therapeutic procedure. The procedure was completed using a similar device. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50752282 ↗MalfunctionSep 11, 2026Activation Failure; Complete Loss of Power
It was reported the Lithotripsy was not powering on. The issue occurred during setup. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732694 ↗MalfunctionSep 10, 2026Failure to Deliver Energy
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721439 ↗MalfunctionSep 10, 2026Loss of Power; Unexpected Shutdown; No Visual Prompts/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718433 ↗MalfunctionSep 9, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701797 ↗MalfunctionSep 9, 2026Loose or Intermittent Connection; No Visual Prompts/Feedback
The customer returned the LITHOTRIPSY SYSTEM for a separate issue. During the initial evaluation of the returned device, Due to poor contact of transducer socket, press the "S" button on the transducer and hold it, "Standard Power" light is not illuminating green was found. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696044 ↗MalfunctionSep 9, 2026Break
The customer reported connector broke during set up / Inspection for use involving an Olympus LITHOTRIPSY TRANSDUCER. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693667 ↗MalfunctionSep 9, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693253 ↗
Other Gyrus ACMI, LLC products
- SOLTIVE16 models · 867 reports · 17 recalls
- Olympus27 models · 518 reports · 21 recalls
- EZDilate7 models · 33 reports · 6 recalls
- Spiration Valve System10 models · 242 reports · 1 recall
- BiCOAG4 models · 36 reports · 5 recalls
- USA Elite24 models · 78 reports · 3 recalls
- M3 Gold5 models · 30 reports · 2 recalls
- PK TECHNOLOGY10 models · 24 reports · 2 recalls
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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