InterPulseRecalls & reported problems across all models
Stryker Corporation · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 177
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 18 models of InterPulse by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 177 adverse event reports in the FDA's MAUDE database, received between Dec 12, 2016 and Jun 10, 2026 — classified as 177 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (69 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
InterPulse 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.
- Nov 9, 2017Terminated
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Z-1246-2018 · Root cause: Environmental control · names 4 of these models · Recall details · FDA record ↗
Most reported InterPulse problems
Device problems
- Delivered as Unsterile Product69
- Fluid/Blood Leak32
- Leak/Splash26
- Detachment of Device or Device Component13
- Device Contaminated During Manufacture or Shipping9
- Fracture7
- Overheating of Device7
- Battery Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions92
- No Consequences Or Impact To Patient73
- No Patient Involvement15
- No Known Impact Or Consequence To Patient5
- Insufficient Information2
- Burn(s)1
InterPulse models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- InterPulse 0210114100LAVAGE, JET1 recall21 reports
- InterPulse 0210110100LAVAGE, JET1 recall5 reports
- InterPulse 0210118200LAVAGE, JET1 recall1 report
- InterPulse 0210218000LAVAGE, JET1 recall0 reports
- InterPulse 0210114000LAVAGE, JET41 reports
- InterPulse 0210112000LAVAGE, JET20 reports
- InterPulse 0210110000LAVAGE, JET20 reports
- InterPulse 0210200000LAVAGE, JET15 reports
- Interpulse 0210158000LAVAGE, JET15 reports
- InterPulse 0210100000LAVAGE, JET14 reports
- InterPulse 0210214000LAVAGE, JET8 reports
- InterPulse 0210118000LAVAGE, JET6 reports
- InterPulse 0210166000LAVAGE, JET3 reports
- InterPulse 0210212000LAVAGE, JET2 reports
- InterPulse 0210118100LAVAGE, JET2 reports
- InterPulse 0210210000LAVAGE, JET2 reports
- InterPulse 0211100000LAVAGE, JET1 report
- InterPulse 0210112000ELAVAGE, JET1 report
Recent InterPulse adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, IT WAS REPORTED THAT A PIECE OF THE IRRIGATOR DETACHED WITHOUT BEING NOTICED AT THE TIME OF OCCURRENCE. SUBSEQUENTLY, A SMALL PLASTIC FRAGMENT WAS DISCOVERED WITHIN THE PATIENT'S RIGHT HIP JOINT SPACE. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED, AND THE JOINT SPACE WAS INSPECTED. NO ADDITIONAL DETACHED MATERIAL OR DEVICE FRAGMENTS WERE IDENTIFIED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25455918 ↗MalfunctionOct 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) - (B)(6) 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368312 ↗MalfunctionJul 30, 2025Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: OVERHEATING OF DEVICE. 1 EVENT HAD MINOR INJURY/ ILLNESS / IMPAIRMENT.
Patient problems: Burn(s)
MAUDE report 22663294 ↗MalfunctionJul 24, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN APRIL 1 ¿ JUNE 30, 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DEVICE CONTAMINATED DURING MANUFACTURE OR SHIPPING. - 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22587146 ↗MalfunctionJul 24, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN APRIL 1 ¿ JUNE 30, 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DEVICE CONTAMINATED DURING MANUFACTURE OR SHIPPING. - 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22587118 ↗MalfunctionJul 24, 2025Fracture; Fracture
THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22586859 ↗MalfunctionApr 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY CONTAMINATED DURING MANUFACTURE OR SHIPPING. - 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21878615 ↗MalfunctionApr 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY CONTAMINATED DURING MANUFACTURE OR SHIPPING. 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21878610 ↗MalfunctionApr 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY CONTAMINATED DURING MANUFACTURE OR SHIPPING. - 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21878609 ↗MalfunctionApr 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY CONTAMINATED DURING MANUFACTURE OR SHIPPING. - 3 EVENTS HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21878600 ↗MalfunctionApr 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY CONTAMINATED DURING MANUFACTURE OR SHIPPING. - 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21878599 ↗MalfunctionJan 22, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY CONTAMINATED DURING MANUFACTURE OR SHIPPING. - 3 EVENTS HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21207635 ↗MalfunctionJan 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 0 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21207500 ↗MalfunctionJan 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY LEAKING.1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21200281 ↗MalfunctionJan 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. - 2 EVENTS HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE. -THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21200277 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 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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