SYNCHRO 2Recalls & reported problems across all models

We found 8 models of SYNCHRO 2 by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 313 adverse event reports in the FDA's MAUDE database, received between Jan 27, 2017 and Sep 24, 2026 — classified as 88 injuries, 225 malfunctions.

The most frequently reported specific device problem is “Fracture” (192 reports).

9 FDA recall records 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

SYNCHRO 2 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.

1. 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-1941-2024 · Root cause: Component design/selection · names 8 of these models · Recall details · FDA record ↗

2. Jun 8, 2018Terminated

   The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

   Z-0232-2020 · Root cause: Employee error · Recall details · FDA record ↗

3. Jun 8, 2018Terminated

   The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

   Z-0231-2020 · Root cause: Employee error · Recall details · FDA record ↗

4. Jun 8, 2018Terminated

   The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

   Z-0230-2020 · Root cause: Employee error · Recall details · FDA record ↗

5. Jun 8, 2018Terminated

   The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

   Z-0229-2020 · Root cause: Employee error · Recall details · FDA record ↗

6. Jun 8, 2018Terminated

   The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

   Z-0228-2020 · Root cause: Employee error · Recall details · FDA record ↗

7. Jun 8, 2018Terminated

   Z-0227-2020 · Root cause: Employee error · Recall details · FDA record ↗

8. Jun 8, 2018Terminated

   The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

   Z-0226-2020 · Root cause: Employee error · Recall details · FDA record ↗

9. Jun 8, 2018Terminated

   The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

   Z-0225-2020 · Root cause: Employee error · Recall details · FDA record ↗

Most reported SYNCHRO 2 problems

SYNCHRO 2 models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SYNCHRO 2 M00326410

  WIRE, GUIDE, CATHETER
  2 recalls155 reports
• SYNCHRO 2 M00326010

  WIRE, GUIDE, CATHETER
  2 recalls79 reports
• SYNCHRO 2 M00326510

  WIRE, GUIDE, CATHETER
  2 recalls41 reports
• SYNCHRO 2 M00326420

  WIRE, GUIDE, CATHETER
  2 recalls18 reports
• SYNCHRO 2 M00326110

  WIRE, GUIDE, CATHETER
  2 recalls14 reports
• SYNCHRO 2 M00326310

  WIRE, GUIDE, CATHETER
  2 recalls5 reports
• SYNCHRO 2 M00326520

  WIRE, GUIDE, CATHETER
  2 recalls1 report
• SYNCHRO 2 M00326320

  WIRE, GUIDE, CATHETER
  2 recalls0 reports

Recent SYNCHRO 2 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Fracture

  It was reported that during a stroke procedure, the subject guidewire broke off and a portion of the device remained within the patient. Attempts were made to aspirate and remove the retained guidewire fragment; however, these attempts were unsuccessful. There is no additional information available.

  Patient problems: Foreign Body In Patient

  MAUDE report 50889676 ↗
• MalfunctionSep 21, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845436 ↗
• MalfunctionSep 2, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50555072 ↗
• MalfunctionAug 27, 2026Fracture

  It was reported that a patient with a basilar artery tip aneurysm underwent a stent-assisted coil embolization procedure. A subject guidewire positioned the microcatheter in the distal posterior cerebral artery and was then removed. The physician then used the subject guidewire to deliver another microcatheter into the aneurysm sac. However, immediately after the subject guidewire was inserted into the microcatheter, the resistance was encountered and could not be advanced further. Therefore, the subject guidewire was withdrawn, and the distal tip of the subject guidewire was observed to be fractured exactly at the microcatheter hub. Additional information further confirmed that the fractured distal tip of the subject guidewire was within the microcatheter shaft. The microcatheter was removed, and the fractured guidewire segment was successfully retrieved on the table. The subject guidewire was replaced, and the procedure was completed successfully with no reported clinical consequences to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50475221 ↗
• MalfunctionAug 26, 2026Peeled/Delaminated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461647 ↗
• InjuryAug 14, 2026Fracture

  It was reported that during one procedure for middle cerebral artery (MCA) stenosis, the physician delivered the intermediate catheter smoothly to the lesion site, then exchanged for the subject guidewire. When torquing the subject guidewire, the physician found that the distal tip of the subject guidewire fractured. The physician then used a Gateway balloon to clamp the fractured guidewire and retrieve it. The patient was reported to be fine. 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 50250148 ↗
• InjuryJul 30, 2026Fracture

  It was reported during a Middle Cerebral Artery (MCA) occlusion thrombectomy procedure when the subject guidewire was advanced to the M2 segment of the MCA it fractured at the distal end of the internal carotid artery. The physician used a balloon and intermediate catheter to retrieve the fractured guidewire from the vessel and remove it from the patient. The guidewire was removed and replaced resulting in a 10 minute surgical delay. The procedure was completed successfully with no clinical consequences to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50092618 ↗
• InjuryJul 17, 2026Fracture

  IT WAS REPORTED THAT DURING A MCA STENOSIS TREATMENT, WHEN THE PHYSICIAN DEPLOYED A NON-STRYKER STENT AT THE TREATMENT SITE, IT WAS NOT APPOSING TO THE VESSEL WALLS. THE PHYSICIAN USED THE SUBJECT GUIDEWIRE TO TRY TO OPEN THE STENT. DURING THE MANIPULATION, THE GUIDEWIRE TIP FRACTURED AT THE PROXIMAL END OF THE STENT. THE TIP OF THE GUIDEWIRE REMAINED LODGED INSIDE THE STENT AND WAS NOT RETRIEVED. THERE WAS A SURGICAL DELAY OF 1 HOUR. POSTOPERATIVELY, THE PATIENT DEVELOPED CONTRALATERAL LIMB HEMIPLEGIA. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque; Paralysis

  MAUDE report 25854901 ↗
• MalfunctionJul 16, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25846756 ↗
• MalfunctionJul 9, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25764490 ↗
• MalfunctionJun 16, 2026Fracture

  IT WAS REPORTED THAT DURING A STROKE TREATMENT PROCEDURE ((THROMBECTOMY), THE TIP OF THE SUBJECT GUIDEWIRE DETACHED. THE SUBJECT GUIDEWIRE WAS DETACHED FROM ITS DISTAL PART MOSTLY WITHIN THE MICROCATHETER AND WAS RETRIEVED BY REMOVING THE MICROCATHETER. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25519896 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING THE CLINICAL TRAIL 9 MONTHS POST-PROCEDURE THE IMPLANTED FLOW-DIVERTER STENT HAD STENOSIS IN THE CAVERNOUS SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY WITH POSSIBLE RELATION TO THE SUBJECT GUIDEWIRE. THE PHYSICIAN PERFORMED A BALLOON ANGIOPLASTY AND ADDITIONAL STENT IMPLANTATION FOR THE STENOSIS. THE EVENT WAS RESOLVED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Stenosis

  MAUDE report 24958302 ↗
• MalfunctionMar 6, 2026Fracture

  THE GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS OBSERVED THAT THE DISTAL TIP OF SUBJECT GUIDEWIRE WAS FRACTURED DURING USE. ALSO, THE MID SECTION OF THE SUBJECT GUIDEWIRE WAS NOTED TO BE KINKED/BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539086 ↗
• MalfunctionJan 22, 2026Fracture

  IT WAS REPORTED THAT DURING INTRACRANIAL STENOSIS PROCEDURE, WHILE DELIVERING THE SUBJECT GUIDEWIRE THROUGH THE LESION SITE, THE PHYSICIAN SUSPECTED THAT THE MIDDLE PART OF THE SUBJECT GUIDEWIRE HAD FRACTURED AND WITHDRAWN IT. UPON INSPECTION, THE SUBJECT GUIDEWIRE TIP WAS FOUND TO BE BROKEN. AFTER THAT, IN THE SAME PROCEDURE, THE STENT WAS PREPARED TO DEPLOY BUT RESISTANCE WAS FELT WHEN IT ENTERED THE MICROCATHETER AND PREVENTED IT FROM BEING ADVANCED AND LATER ON THE STENT WAS WITHDRAWN AND PARTIALLY REFRACTED IT INTO THE INTRODUCER SHEATH AND ALSO RESISTANCE WAS FELT WHEN REMOVING THE SUBJECT GUIDEWIRE FROM DISPENSER HOOP. 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 24152573 ↗
• MalfunctionDec 23, 2025Peeled/Delaminated; Peeled/Delaminated

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE GUIDEWIRE (SUBJECT DEVICE) PTFE COATING WAS PEELING. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885915 ↗

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
• Neptune E-SEP19 models · 412 reports · 7 recalls
• StrykeFlow4 models · 552 reports · 4 recalls
• InTouch5 models · 666 reports · 1 recall