Synchro2 S2SPP14215Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327459654), received between Feb 4, 2020 and Apr 26, 2024 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 reports).

1 FDA recall record name this device's 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, 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

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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE SUBJECT GUIDEWIRE WAS BROKEN AND REMAINED IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19197260 ↗
• MalfunctionSep 15, 2023Fracture; Peeled/Delaminated; Fracture; Peeled/Delaminated

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT GUIDEWIRE HAD PTFE (POLYTETRAFLUOROETHYLENE) COATING PEELING ISSUE AND THE SUBJECT GUIDEWIRE DISTAL TIP 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 17761590 ↗
• InjuryAug 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE THE DISTAL PART OF THE SUBJECT GUIDEWIRE BROKE DURING USE. STENT THROMBECTOMY WAS PERFORMED TO REMOVE THE BROKEN GUIDEWIRE FROM THE PATIENTS BODY. THE BROKEN PIECE WAS REMOVED SUCCESSFULLY WHICH DID NOT INFLUENCE THE OUTCOME OF THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17502863 ↗
• InjuryFeb 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE (SUBJECT DEVICE) WAS SHEARED OFF WHEN CROSSING OCCLUSION DURING MANIPULATION OF THE WIRE ATTEMPTING TO CROSS THROMBUS, PHYSICIAN NOTICED THAT HE HAD LOST 1 TO 1 TORQUE RESPONSE. PART OF THE GUIDEWIRE (SUBJECT DEVICE) WAS LEFT IN THE PATIENT AND STENT PLACEMENT WAS PERFORMED AS A MEDICAL INTERVENTION. PATIENT STATUS IS STABLE. NIHSS (NATIONAL INSTITUTES OF HEALTH STROKE SCALE) PRE PROCEDURE WAS 23 AND POST PROCEDURE WAS 7. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16391604 ↗
• InjuryNov 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE TORN OFF DURING USE. THE DEVICE WAS REMOVED WITH THE HELP OF A SNARE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15869156 ↗
• MalfunctionDec 20, 2021Fracture; Peeled/Delaminated; Fracture; Peeled/Delaminated

  IT WAS REPORTED THAT DURING PREPARATION, THE GUIDEWIRE (SUBJECT DEVICE) HAD A "PIG-TAIL" SHAPED TIP. WHEN THE GUIDEWIRE (SUBJECT DEVICE) WAS USED AGAIN, THE INSERTION AID WAS USED. FOR THIS PURPOSE, IT WAS PUSHED OVER THE WIRE FROM BEHIND. IT WAS NOTICED THAT PARTICLES OF THE OUTER COATING OF THE GUIDE WIRE (SUBJECT DEVICE) WERE COMING LOOSE. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 13049575 ↗
• InjuryDec 13, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO HOSPITAL WITH THE MAJOR STROKE. THE SUBJECT WIRE ALONG WITH OTHER DEVICES WERE USED TO REMOVE THE HARD CLOT LOCATED AT THE LEFT POSTERIOR VIA THE INTERNAL CAROTID ARTERY. WHILE PROBING, THE TIP OF THE WIRE (SUBJECT DEVICE) GOT STUCK IN THE CLOT/STENOSIS AND WHILE TWISTING ON PROXIMAL SIDE THE SUBJECT WIRE WAS TORN OFF AND CAUSED A 120-MINUTE SURGICAL DELAY. THE ASS MEDICAL INTERVENTION WAS PERFORMED TO RETRACT THE BROKEN SUBJECT WIRE BUT UNSUCCESSFUL AS IT REMAINED INSIDE THE PATIENT. IN THE PROCESS, A PROBABLY HARD THROMBUS WAS PASSED. IT WAS LATER REPORTED THAT THE PATIENT HAD PASSED AWAY DUE TO PRESENTING ISCHEMIC STROKE CONDITION PRIOR TO TREATMENT AND THE OUTCOME OF PATIENT DEATH WAS NOT RELATED TO THE SUBJECT WIRE DEVICE. UPDATE : IT WAS CONFIRMED THAT THE PROBABLY HARD THROMBUS WAS PASSED THAT OCCURRED IN THE SAME TERRITORY AS THE EMBOLISM. THE PHYSICIAN TRIED TREAT THE THROMBUS BY USING AN ASPIRATION CATHETER FIRST. AFTER THAT DIDN¿T WORK THEY TRIED USING A STENT RETRIEVER. ACCORDING TO THE PHYSICIAN INDICATED THAT THE HARD THROMBUS WAS NOT RELATED TO THE SUBJECT SYNCHRO.

  Patient problems: Embolism/Embolus; Foreign Body In Patient

  MAUDE report 12984972 ↗
• InjurySep 27, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING ONYX EMBOLIZATION PROCEDURE OF A ARTERIOVENOUS FISTULA, THE DISTAL END OF THE SUBJECT GUIDEWIRE BROKE OFF INSIDE THE PATIENT. THE SUBJECT GUIDEWIRE TIP REMAINS INSIDE THE PATIENT AND IT WAS EMBOLIZED INTO THE FISTULA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO SNARE DEVICE WAS USED AND THE PATIENT WAS DOING WELL. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12533143 ↗
• MalfunctionJan 20, 2021Fracture; Fracture

  INITIALLY IT WAS REPORTED THAT THE GUIDEWIRE DISTAL TIP WAS NOTED TO BE STRETCHED WHEN REMOVED FROM THE PATIENT ANATOMY. THE GUIDEWIRE (SUBJECT DEVICE) 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 11206120 ↗
• InjuryDec 22, 2020Fracture; Peeled/Delaminated; Fracture; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT GUIDE WIRE BROKE INSIDE THE PATIENT. A SNARE DEVICE WAS USED TO RETRACT THE BROKEN PIECE OF THE SUBJECT GUIDE WIRE. 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 11059831 ↗
• MalfunctionDec 9, 2020Fracture; Fracture

  THE GUIDEWIRE (SUBJECT DEVICE) 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 10974153 ↗
• InjuryFeb 4, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT A TO TREAT BASILAR STENOSIS, THE PHYSICIAN WAS GOING TO IMPLANT A STENT OVER A GUIDEWIRE DISTAL PART (SUBJECT DEVICE) AND THE GUIDEWIRE BROKE OFF IN THE BASILAR ARTERY IN THE PATIENT. THE PHYSICIAN SUCCESSFULLY SNARED THE DISTAL PIECE OF GUIDEWIRE THAT BROKE OFF. THE STENTING PROCEDURE WAS ABORTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9668879 ↗