SYNCHRO 10 M00316330Recalls & reported problems
Stryker Corporation · Neuro Guidewire with Hydrophilic Coating · Class 2
All models of SYNCHRO 10 (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613252187165), received between Jan 15, 2019 and Nov 9, 2021 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (2 reports).
2 FDA recall records name this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- 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 · 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Peeled/Delaminated2
- Break1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionFeb 2, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE FOR MCA STENOSIS CASE, A GUIDEWIRE WAS USED TO BRING BALLOON CATHETER TO TARGET LESION. PHYSICIAN THEN WITHDREW THE INITIAL GUIDEWIRE AND PLACED SUBJECT GUIDEWIRE TO CONTINUE PROCEDURE. WHEN THE SUBJECT GUIDEWIRE WAS DELIVERED ALONG WITH THE BALLOON CATHETER, PHYSICIAN FOUND THAT THE TIP OF THE GUIDEWIRE COULD NOT BE SEEN UNDER DSA AND BELIEVED TO HAVE BEEN DELIVERED INTO VESSEL FOR ABOUT 1M. IN ORDER TO AVOID ANY RISK, THE PHYSICIAN REPLACED SUBJECT GUIDEWIRE ANOTHER OF THE SAME CATALOG TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11269969 ↗InjuryMay 10, 2019Break; Break
IT WAS REPORTED DURING TREATMENT OF A STROKE, THE DISTAL END OF THE GUIDEWIRE(SUBJECT DEVICE) BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN REMOVED THE BROKEN WIRE WITH A SNARE DEVICE AND COMPLETED THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8601822 ↗MalfunctionJan 15, 2019Peeled/Delaminated; Peeled/Delaminated
THE INVESTIGATION OF THE RETURNED SUBJECT DEVICE REVEALED THAT THE POLYTETRAFLUOROETHYLENE (PTFE) WAS PEELED/SCRAPED OFF. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8251018 ↗
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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