SYNCHRO 10Recalls & reported problems across all models
Stryker Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one SYNCHRO 10 model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls
- 2
We found 2 models of SYNCHRO 10 by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2018 and Oct 21, 2025 — classified as 16 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (24 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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
SYNCHRO 10 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.
- Apr 23, 2024Open, Classified
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
Z-1909-2024 · Root cause: Process design · names 2 of these models · Recall details · FDA record ↗
- Apr 18, 2024Open, Classified
Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.
Z-1939-2024 · Root cause: Component design/selection · names 2 of these models · Recall details · FDA record ↗
Most reported SYNCHRO 10 problems
Device problems
- Peeled/Delaminated24
- Fracture20
- Break4
- Material Fragmentation1
- Premature Activation1
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- No Consequences Or Impact To Patient8
- Device Embedded In Tissue or Plaque3
- Foreign Body In Patient3
- Hemorrhage/Blood Loss/Bleeding1
- No Known Impact Or Consequence To Patient1
SYNCHRO 10 models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SYNCHRO 10 M00316310WIRE, GUIDE, CATHETER2 recalls44 reports
- SYNCHRO 10 M00316330WIRE, GUIDE, CATHETER2 recalls4 reports
Recent SYNCHRO 10 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2025Peeled/Delaminated; Peeled/Delaminated
THE GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND THE POLY TETRA FLUORO ETHYLENE (PTFE) COATING OVER THE SUBJECT DEVICE WAS NOTED TO BE PEELING. THE PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY, AND NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23348480 ↗MalfunctionMar 6, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING ARTERIOVENOUS MALFORMATION (AVM) CASE, PHYSICIAN ROTATED THE SUBJECT GUIDEWIRE FOR ADVANCEMENT IN PATIENT BODY, BUT THE DISTAL TIP WAS NOT MOVED FOLLOWING THE ROTATION AT PROXIMAL. ON WITHDRAWAL, THE DISTAL TIP OF THE SUBJECT GUIDEWIRE WAS FOUND FRACTURED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18846893 ↗MalfunctionDec 13, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE OPERATOR FOUND THE GUIDEWIRE (SUBJECT DEVICE) COATING PEELED OFF AT DISTAL DURING PREPARATION. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18319391 ↗MalfunctionNov 8, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED DURING AN INTRACRANIAL ARTERIOVENOUS MALFORMATIONS EMBOLIZATION CASE WHEN THE PHYSICIAN WAS MANIPULATING THE SUBJECT GUIDEWIRE, THE GREEN POLYTETRAFLUOROETHYLENE (PTFE) COATING OF THE MIDDLE TO THE PROXIMAL PEELED OFF AND THE OPERATOR FELT BAD MANIPULATION OF THE SUBJECT GUIDEWIRE. THE SUBJECT GUIDEWIRE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18097633 ↗MalfunctionNov 7, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE, THE SUBJECT GUIDEWIRE DISTAL TIP WAS DETACHED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18085375 ↗MalfunctionOct 13, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING CANNULATION, THE TIP OF THE GUIDEWIRE (SUBJECT DEVICE) DETACHED IN A NON-STRYKER MICROCATHETER. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. THE PATIENT CONDITION FOLLOWING PROCEDURE IS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17931944 ↗MalfunctionOct 11, 2023Peeled/Delaminated; Peeled/Delaminated
THE SUBJECT GUIDEWIRE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT GUIDEWIRE PTFE (POLYTETRAFLUOROETHYLENE) COATING WAS NOTED TO BE 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 17913955 ↗MalfunctionSep 21, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT DURING ONE INTRACRANIAL ARTERIOVENOUS MALFORMATIONS EMBOLIZATION CASE, THE OPERATOR USED SUBJECT GUIDEWIRE TO WORK WITH NON-STRYKER MICROCATHETER TO BUILD ACCESS. HOWEVER LARGE AREA OF GREEN COATING PEELED OFF AT THE MIDDLE AND REAR OF THE SUBJECT GUIDEWIRE. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17786801 ↗MalfunctionApr 24, 2023Peeled/Delaminated; Peeled/Delaminated
ANALYSIS OF THE RETURNED SUBJECT GUIDEWIRE REVEALED PEELING OF ITS PTFE COATING. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16802010 ↗InjuryMar 9, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE THE GUIDEWIRE (SUBJECT DEVICE) BECAME DETACHED IN THE PATIENT, AND A PORTION IS STILL STUCK IN PATIENT. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED STATED THAT WHEN THE PHYSICIAN WAS NAVIGATING THE MICROCATHETER IN THE LEFT OCCIPITAL ARTERY, THEY LOST PUSHABILITY OF THE SUBJECT GUIDEWIRE. WHEN THE SUBJECT GUIDEWIRE WAS PULLED BACK, THE PHYSICIAN NOTICED PART OF THE SUBJECT GUIDEWIRE BROKE OFF IN THE LEFT OCCIPITAL ARTERY. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE BROKEN GUIDEWIRE WITH A SNARE AND OCCLUSION BALLOON, HOWEVER, THE GUIDEWIRE WAS NOT REMOVED AND IS CURRENTLY STILL IN THE LEFT OCCIPITAL ARTERY OFF THE LEFT EXTERNAL CAROTID.
Patient problems: Foreign Body In Patient
MAUDE report 16514558 ↗InjuryAug 5, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A LONG DURAL AV FISTULA CASE THE DISTAL TIP OF THE GUIDEWIRE (SUBJECT DEVICE) BROKE OFF AND DISLODGED DISTALLY IN THE PATIENT. A MICRO SNARE DEVICE WAS USED TO RETRIEVE THE TIP AND REMOVED IT FROM THE PATIENT. ACCORDING TO THE TECH, THE SUBJECT GUIDEWIRE WAS USED FOR SEVERAL HOURS BEFORE IT BROKE. ONYX WAS ALSO DELIVERED BY THE SAME MICROCATHETER DURING THE PROCEDURE PRIOR TO THE WIRE BREAKING. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15176695 ↗MalfunctionMar 29, 2022Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT DURING THE PROCEDURE, THE COATING OF THE SUBJECT GUIDEWIRE WAS FOUND PEELED OFF. 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 13945252 ↗MalfunctionMar 19, 2022Peeled/Delaminated; Peeled/Delaminated
THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT PTFE COATING OF THE SUBJECT GUIDEWIRE WAS PEELED OFF. THEREFORE, THIS EVENT MEETS THE REQUIREMENTS OF A REPORTABLE EVENT WITH AN AWARENESS DATE OF (B)(6) 2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13827543 ↗MalfunctionNov 9, 2021Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT DURING THE PROCEDURE OUTSIDE OF THE PATIENT BODY, THE PHYSICIAN FOUND THE SUBJECT GUIDEWIRE PTFE COATING WAS CAME OFF. 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 12776421 ↗MalfunctionOct 12, 2021Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED DURING THE PROCEDURE WHILE SLIDING THE INTRODUCER OVER THE SUBJECT GUIDEWIRE THE PTFE COATING WAS PEELING OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12618983 ↗
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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