Synchro SELECTRecalls & reported problems across all models
Stryker Corporation · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Synchro SELECT model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 303
- Deaths reported
- 1
- Injuries reported
- 68
- Recalls
- 1
We found 11 models of Synchro SELECT by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 303 adverse event reports in the FDA's MAUDE database, received between Mar 15, 2021 and Sep 30, 2026 — classified as 1 death, 68 injuries, 234 malfunctions.
The most frequently reported specific device problem is “Fracture” (182 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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 SELECT 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 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-1940-2024 · Root cause: Component design/selection · names 10 of these models · Recall details · FDA record ↗
Most reported Synchro SELECT problems
Device problems
- Fracture182
- Peeled/Delaminated119
- Adverse Event Without Identified Device or Use Problem9
- Difficult to Insert1
- No Apparent Adverse Event1
- Packaging Problem1
- Unclear Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions268
- Foreign Body In Patient20
- Insufficient Information3
- Perforation of Vessels3
- Device Embedded In Tissue or Plaque2
- Fever2
- Hemorrhage/Blood Loss/Bleeding2
- Hypersensitivity/Allergic reaction2
Synchro SELECT models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Synchro SELECT SSFT215STRWire, guide, catheter1 recall99 reports
- Synchro SELECT SSTD215STRGuide, wire, catheter, neurovasculature1 recall97 reports
- Synchro SELECT SSUP215STRWire, guide, catheter1 recall1 death42 reports
- Synchro SELECT SSFT215PREWire, guide, catheter1 recall21 reports
- Synchro SELECT SSTD215PREGuide, wire, catheter, neurovasculature1 recall16 reports
- Synchro SELECT SSUP215PREGuide, wire, catheter, neurovasculature1 recall11 reports
- Synchro SELECT SSTD300STRWire, guide, catheter1 recall9 reports
- Synchro SELECT SSUP300STRGuide, wire, catheter, neurovasculature1 recall5 reports
- Synchro SELECT SSUP300PREWire, guide, catheter1 recall2 reports
- Synchro SELECT SSFT300STRGuide, wire, catheter, neurovasculature1 recall0 reports
- Synchro SELECT SSTD300PREGuide, wire, catheter, neurovasculature1 report
Recent Synchro SELECT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Ruptured Aneurysm
MAUDE report 50946978 ↗MalfunctionSep 15, 2026Fracture
It was reported that during treatment of a right internal carotid artery (ICA) to middle cerebral artery (MCA) stenosis, a subject guidewire was used in conjunction with a microcatheter to establish access for stent implantation. During advancement of the subject guidewire and microcatheter to the distal ICA, the subject guidewire could not be successfully superselected or positioned. The devices were withdrawn, and it was observed that the subject guidewire tip had stretched. However, The subject guidewire was returned for analysis and was examined. During device investigation and analysis, it was discovered that the subject guidewire distal tip was broken/fractured during use. 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 50774723 ↗MalfunctionAug 27, 2026Peeled/Delaminated
It was reported that during anterior cerebral artery aneurysms procedure, the subject guidewire was delivered through the microcatheter however, the guidewire could not reach the target site as the parent vessel was tortuous and after withdrawing and performing superselective catheterization again, it was found that the guidewire had poor torquability and again upon withdrawal of guidewire out from patient's body, the subject guidewire distal tip was noted to be frayed. 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 50486517 ↗InjuryAug 27, 2026Fracture
It was reported during the thrombectomy procedure while advancing the subject guidewire, and resistance was encountered intravascularly. The distal tip fractured on the guidewire. The detached fragment and thrombus were retrieved using a stent retriever and aspiration catheter. The procedure was completed with no clinical consequences to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50465740 ↗MalfunctionAug 26, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50462577 ↗MalfunctionJul 10, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25775447 ↗MalfunctionJun 26, 2026Fracture
THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE DISTAL TIP OF THE SUBJECT DEVICE WAS BROKEN/FRACTURED DURING USE. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED AS NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25637164 ↗MalfunctionMay 19, 2026Fracture
IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE WAS KINKED. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT GUIDEWIRE WAS BROKEN/FRACTURED DURING USE. 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 25212439 ↗MalfunctionApr 8, 2026Fracture
IT WAS REPORTED THE TIP OF THE SUBJECT GUIDEWIRE BROKE LOOSE, BUT COULD GET OUT OF THE PATIENT. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24816781 ↗MalfunctionApr 8, 2026Fracture
IT WAS REPORTED THAT DURING A PROCEDURE FOR AN EMERGENCY EMBOLIZATION FOR A LEFT MIDDLE CEREBRAL ARTERY BIFURCATION ANEURYSM, THE PHYSICIAN SELECTED A SUBJECT GUIDEWIRE IN CONJUNCTION WITH A MICROCATHETER FOR THE PURPOSE OF SUPER-SELECTING THE ANEURYSM. DURING THE MANIPULATION, THE PHYSICIAN OBSERVED THAT THE TIP OF THE SUBJECT GUIDEWIRE LOST CONTROLLABILITY WITHIN THE MICROCATHETER. FLUOROSCOPIC EXAMINATION REVEALED THAT APPROXIMATELY 10 CENTIMETERS OF THE RADIOPAQUE SEGMENT AT THE SUBJECT GUIDEWIRE TIP HAD FRACTURED. WHILE RETRACTING THE ENTIRE SYSTEM, THE FRACTURED SUBJECT GUIDEWIRE TIP INADVERTENTLY FELL INTO THE PATIENT'S BODY. ULTIMATELY, THE PHYSICIAN SUCCESSFULLY EXTRACTED THE FRACTURED GUIDEWIRE USING A STENT RETRIEVER. THE PHYSICIAN CONCLUDED THE PROCEDURE IMMEDIATELY AND THE PATIENT WAS TRANSFERRED TO A HIGHER-LEVEL HOSPITAL TO CONTINUE TREATMENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24815817 ↗MalfunctionApr 7, 2026Peeled/Delaminated
THE GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS OBSERVED THAT THE GUIDEWIRE POLY TETRA FLUORO ETHYLENE (PTFE) COATING WAS PEELING. ADDITIONALLY, THERE WAS RESISTANCE WITH USE OF GUIDEWIRE AND HAS CHALLENGES WHILE ADVANCING A CATHETER OVER IT. ALSO, THE MIDSECTION AND DISTAL END TIP OF SUBJECT GUIDEWIRE WAS KINKED/BENT. THE SUBJECT DEVICE WAS REPORTED TO BE REPLACED, AND THE PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24807857 ↗MalfunctionApr 6, 2026Fracture
IT WAS REPORTED THAT WHEN THE PHYSICIAN USED A SUBJECT GUIDEWIRE TO GUIDE THE MICROCATHETER INTO PLACE THROUGH SUPER-SELECTIVE CATHETERIZATION, THE PHYSICIAN FOUND THAT THE SUBJECT GUIDEWIRE WAS STRETCHED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE SUBJECT GUIDEWIRE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE DISTAL TIP OF THE SUBJECT GUIDEWIRE WAS BROKEN/FRACTURED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792274 ↗MalfunctionApr 2, 2026Fracture
IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, RESISTANCE WAS ENCOUNTERED WITH THE SUBJECT DEVICE. ALSO, WHEN THE PHYSICIAN ATTEMPTED TO DELIVER THE SUBJECT DEVICE TO THE OCCLUDED SEGMENT THE TIP OF THE SUBJECT DEVICE GOT KINKED. THE PHYSICIAN REMOVED THE SUBJECT DEVICE ALONG WITH THE CATHETER AND FOUND THE TIP OF THE SUBJECT DEVICE TO BE FRACTURED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765986 ↗MalfunctionApr 1, 2026Fracture
IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, THE SUBJECT DEVICE GOT BROKEN DURING THE PROCEDURE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24757474 ↗MalfunctionApr 1, 2026Fracture
IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, THE SUBJECT DEVICE GOT BROKEN DURING THE PROCEDURE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24757463 ↗
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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