Excelsior SL-10Recalls & reported problems across all models
Stryker Corporation · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 213
- Deaths reported
- 2
- Injuries reported
- 35
- Recalls
- 0
We found 7 models of Excelsior SL-10 by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 213 adverse event reports in the FDA's MAUDE database, received between May 9, 2016 and Sep 30, 2026 — classified as 2 deaths, 35 injuries, 176 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (101 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 Excelsior SL-10 problems
Device problems
- Peeled/Delaminated101
- Fracture37
- Break22
- Adverse Event Without Identified Device or Use Problem21
- Material Puncture/Hole15
- Component Missing7
- Fluid/Blood Leak2
- Insufficient Device Problem Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions140
- No Consequences Or Impact To Patient41
- Device Embedded In Tissue or Plaque8
- Foreign Body In Patient7
- Vasoconstriction5
- Ruptured Aneurysm4
- Headache3
- No Known Impact Or Consequence To Patient3
Excelsior SL-10 models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Excelsior SL-10 M0031681890CATHETER, PERCUTANEOUS2 deaths143 reports
- Excelsior SL-10 M0031681900CATHETER, PERCUTANEOUS47 reports
- Excelsior SL-10 M0031681910CATHETER, PERCUTANEOUS12 reports
- Excelsior SL-10 M0031681920CATHETER, PERCUTANEOUS5 reports
- Excelsior SL-10 M0031681810CATHETER, PERCUTANEOUS4 reports
- Excelsior SL-10 M0031681930CATHETER, PERCUTANEOUS1 report
- Excelsior SL-10 M0031681940CATHETER, PERCUTANEOUS1 report
Recent Excelsior SL-10 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948924 ↗MalfunctionSep 25, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906143 ↗MalfunctionSep 22, 2026Peeled/Delaminated
It was initially reported that during PComA aneurysm coil embolization procedure, when the stent was advancing through the subject microcatheter, the stent got stuck in the middle of the subject microcatheter. The physician withdrew the stent together with the subject microcatheter out of the body, switched to a different brand of microcatheter and stent, and the procedure was successfully completed. The subject catheter was returned for analysis and examined. The returned catheter showed peeling of its Polytetrafluoroethylene (PTFE) inner lining during investigation. No clinical consequences to the patient were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50850070 ↗MalfunctionSep 10, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714424 ↗MalfunctionAug 18, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50302415 ↗MalfunctionAug 17, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50286351 ↗MalfunctionAug 7, 2026Peeled/Delaminated
The subject microcatheter was returned for analysis and the device investigation revealed that Polytetrafluoroethylene (PTFE) lining was peeled. No clinical consequences were reported to the patient due to this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50184529 ↗MalfunctionJun 5, 2026Peeled/Delaminated
THE SUBJECT MICROCATHETER WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THERE WAS AN UNKNOWN MATERIAL PRESENT ON THE STENT AND POSSIBLY IT MIGHT BE SOME SORT OF TUBING LIKE POLYTETRAFLUOROETHYLENE (PTFE) FROM THE SUBJECT MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25408965 ↗MalfunctionMay 20, 2026Insufficient Device Problem Information
THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT CATHETER PTFE POLYTETRAFLUOROETHYLENE INNER LINING WAS PEELED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25234401 ↗MalfunctionMay 19, 2026Peeled/Delaminated
THE CATHETER (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT DEVICE PTFE (POLYTETRAFLUOROETHYLENE) INNER LINING WAS REMOVED (PEELED) DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25212381 ↗MalfunctionMay 8, 2026Peeled/Delaminated
THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT CATHETER PTFE POLYTETRAFLUOROETHYLENE INNER LINING WAS PEELED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25124384 ↗MalfunctionMay 8, 2026Peeled/Delaminated
THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT CATHETER PTFE POLYTETRAFLUOROETHYLENE INNER LINING WAS PEELED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25120132 ↗MalfunctionApr 30, 2026Peeled/Delaminated
THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT CATHETER PTFE POLYTETRAFLUOROETHYLENE INNER LINING WAS PEELED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25047136 ↗MalfunctionApr 14, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE STENTS WOULD NOT GO THROUGH THE SUBJECT MICROCATHETER. THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND WAS EXAMINED. DURING DEVICE INVESTIGATION AND ANALYSIS, IT WAS DISCOVERED THAT THE SUBJECT CATHETER HAD PTFE INNER LINING PEELING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24873240 ↗MalfunctionApr 13, 2026Peeled/Delaminated
IT WAS REPORTED THAT DURING AN ANEURYSM PROCEDURE, THE PHYSICIAN ENCOUNTERED INCREASED RESISTANCE WHEN THE GUIDEWIRE REACHED THE MID-SECTION OF THE SUBJECT MICROCATHETER. HOWEVER, THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND WAS EXAMINED. DURING DEVICE INVESTIGATION AND ANALYSIS, IT WAS DISCOVERED THAT THE SUBJECT CATHETER HAD PTFE INNER LINING PEELING. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24866249 ↗
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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