SYNCHRO 2 M00326410Recalls & reported problems
Stryker Corporation · Standard Guidewire with Hydrophilic Coating · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Stryker Synchro 2 guidewire guides catheters through blood vessels in the brain and body. Its 153 reports mostly describe the wire fracturing or breaking, and some describe the coating peeling. The reports include no deaths and 34 injuries, and 119 are malfunctions. Of its 2 recalls, one is open for coating damage on certain lots and one is closed. Reports dropped from 35 in the year before to 8 in the latest year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 155
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 155 adverse event reports that list this exact device (DI 04546540688767), received between Jan 4, 2018 and Sep 24, 2026 — classified as 35 injuries, 120 malfunctions.
The most frequently reported specific device problem is “Fracture” (98 reports).
2 FDA recall records name this device's identifier, 1 still open.
12 other recalls cover devices cleared under the same FDA submission (K053268); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- 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 · FDA record ↗
- 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 · FDA record ↗
Most reported problems
Device problems
- Fracture98
- Peeled/Delaminated38
- Break12
- Adverse Event Without Identified Device or Use Problem8
- Deformation Due to Compressive Stress1
- Difficult to Remove1
- Physical Resistance/Sticking1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions103
- No Consequences Or Impact To Patient24
- Foreign Body In Patient10
- Hydrocephalus7
- Device Embedded In Tissue or Plaque5
- Insufficient Information2
- No Known Impact Or Consequence To Patient2
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 155 reports, 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 ↗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 ↗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 ↗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 ↗MalfunctionDec 16, 2025Fracture; Fracture
IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) WAS USED IN THE PROCEDURE. HOWEVER, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE SUBJECT DEVICE. WHEN OBSERVED IN FLUOROSCOPE IT WAS NOTICED THAT THE DISTAL END OF SUBJECT DEVICE WAS KINKED AND FRACTURED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23813475 ↗MalfunctionDec 4, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE FOR THE MIDDLE CEREBRAL ARTERY INTERNAL CAROTID ARTERY LESION, THE PHYSICIAN ATTEMPTED TO PASS THE GUIDEWIRE THROUGH THE LESION SITE. WHEN MANIPULATING THE PROXIMAL END OF THE GUIDEWIRE, THERE WAS NO FEEDBACK FROM THE DISTAL END. THE PHYSICIAN IMMEDIATELY WITHDREW THE GUIDEWIRE AND FOUND THAT IT HAD FRACTURED. THE SUBJECT GUIDEWIRE 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 23721314 ↗InjuryNov 14, 2025Fracture; Fracture
DURING AN ONYX EMBOLIZATION OF THE DURAL AVF ARTERIOVENOUS FISTULA, THE SUBJECT GUIDEWIRE FRACTURED AND RESULTED IN SERIOUS/IMPORTANT MEDICAL EVENT. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 23562757 ↗MalfunctionOct 8, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING PROCEDURE FOR MIDDLE CEREBRAL ARTERY STENOSIS, THE TIP OF THE SUBJECT GUIDEWIRE SUDDENLY STOPPED MOVING IN RESPONSE TO PROXIMAL MANIPULATION. WHEN THE PHYSICIAN ATTEMPTED TO WITHDRAW THE GUIDEWIRE, THE TIP REMAINED STATIONARY. SUBSEQUENTLY, THE MICROCATHETER AND GUIDEWIRE WERE WITHDRAWN FROM THE BODY SIMULTANEOUSLY. UPON EXAMINATION OUTSIDE THE BODY, IT WAS FOUND THAT THE DISTAL END OF THE GUIDEWIRE HAD FRACTURED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23241577 ↗MalfunctionSep 16, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PHYSICIAN USED THE SUBJECT GUIDEWIRE TO ADVANCE THE MICROCATHETER. HOWEVER, DURING SUPERSELECTIVE CATHETERIZATION, THE PHYSICIAN ENCOUNTERED DIFFICULTY IN MANEUVERING THE GUIDEWIRE SMOOTHLY. UPON INSPECTION OUTSIDE THE BODY, IT WAS DISCOVERED THAT THE TIP OF THE SUBJECT GUIDEWIRE HAD DEFORMED. THE PHYSICIAN REPLACED THE GUIDEWIRE WITH ANOTHER GUIDEWIRE, BUT THE SAME ISSUE OCCURRED DURING USE. THE PHYSICIAN REPLACED BOTH THE MICROCATHETER AND THE GUIDEWIRE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE PROXIMAL POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS NOTED TO BE PEELED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23066495 ↗MalfunctionAug 25, 2025Fracture; Fracture
DURING A SURGICAL PROCEDURE FOR A WIDE-NECKED ANEURYSM IN THE M2 SEGMENT OF THE RIGHT MCA MIDDLE CEREBRAL ARTERY, WHEN THE PHYSICIAN WAS USING A SUBJECT GUIDEWIRE FOR DELIVERY, IT WAS FOUND THAT THE SUBJECT GUIDEWIRE HAD FRACTURED INSIDE THE INTERMEDIATE CATHETER. AFTER THE PHYSICIAN WITHDREW THE INTERMEDIATE CATHETER AND REMOVED THE BROKEN SUBJECT GUIDEWIRE, THEY REPLACED IT WITH A NEW GUIDEWIRE, AND THE SURGERY WAS ULTIMATELY COMPLETED WITHOUT ANY CLINICAL CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22885748 ↗MalfunctionJul 25, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE OF M1 SEGMENT OF RIGHT MIDDLE CEREBRAL ARTERY (MCA), THE PHYSICIAN USED THE SUBJECT GUIDEWIRE WITH A MICROCATHETER TO DELIVER THE DISTAL ACCESS CATHETER INTO THE VESSEL, AND THE PATIENT'S ACCESS WAS NOT TORTUOUS. AFTER THE SUBJECT GUIDEWIRE REACHED THE M1 SEGMENT OF THE MCA, IT TWISTED SLIGHTLY. UPON FLUOROSCOPIC OBSERVATION, A SLIGHT CREASE/KINK WAS FOUND ON THE GUIDEWIRE, SO THE GUIDEWIRE WAS WITHDRAWN FOR OBSERVATION, AND A FRACTURE MARK WAS DISCOVERED FROM THE MIDDLE TO PROXIMAL END OF THE GUIDEWIRE. 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 22610753 ↗MalfunctionJul 25, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A MIDDLE CEREBRAL ARTERY (MCA) THROMBECTOMY CASE, THE PHYSICIAN OBSERVED UNDER IMAGING THAT THE TIP OF THE SUBJECT GUIDEWIRE HAD FRACTURED. SUBSEQUENTLY, THE PHYSICIAN WITHDREW THE MICROCATHETER AND GUIDEWIRE AND FOUND THAT APPROXIMATELY 7 CM OF THE TIP OF THE SUBJECT GUIDEWIRE HAD FRACTURED AND FRAYED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22610734 ↗MalfunctionJul 21, 2025Fracture; Fracture
IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) WAS USED IN AN ASPIRATION PROCEDURE. HOWEVER, WHEN THE PROXIMAL END OF GUIDEWIRE WAS ROTATED THERE WAS NO REACTION AT THE DISTAL END. ALSO, WHEN THE GUIDEWIRE WAS RETRACTED AFTER THE PROCEDURE THE PHYSICIAN OBSERVED FRACTURE MARKS ON THE DISTAL END OF THE GUIDEWIRE. 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 22560730 ↗InjuryJun 16, 2025Fracture; Fracture
DURING ACUTE RECANALIZATION PROCEDURE FOR RIGHT ANTERIOR CEREBRAL ARTERY OCCLUSION PROCEDURE, THE OPERATOR DELIVERED THE INTERMEDIATE CATHETER TO THE TERMINAL SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) AND ATTEMPTED TO CROSS THE LESION USING THE SUBJECT GUIDEWIRE WITH A MICROCATHETER. THE GUIDEWIRE WAS FLUSHED AND SUCCESSFULLY DELIVERED THROUGH THE OCCLUDED SEGMENT. THE OPERATOR CONTINUED TO MANIPULATE IT, HOWEVER, THE SUBJECT GUIDEWIRE GOT FRACTURED INSIDE THE ANTERIOR CEREBRAL ARTERY (ACA). SUBSEQUENTLY, THE OPERATOR USED A RETRIEVER STENT TO ENTANGLE THE SUBJECT GUIDEWIRE AND SUCCESSFULLY WITHDREW IT FROM THE PATIENT'S ANATOMY. THE PATIENT IS IN COMA AND THE CAUSE OF COMA IS UNKNOWN.
Patient problems: Coma
MAUDE report 22213408 ↗MalfunctionJun 10, 2025Fracture; Fracture
IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) FAILED TO CROSS THE LESION WHEN ATTEMPTED TO ADVANCE IT THROUGH THE OCCLUDED SEGMENT. ALSO, THE TIP OF THE SUBJECT DEVICE WAS FOUND TO BE FRACTURED WHEN THE PHYSICIAN WITHDREW IT FOR INSPECTION. 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 22181261 ↗MalfunctionMay 19, 2025Fracture; Fracture
IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) WAS SELECTED FOR A THROMBECTOMY PROCEDURE FOR MIDDLE CEREBRAL ARTERY OCCLUSION. HOWEVER, DIFFICULTY WAS ENCOUNTERED BY THE PHYSICIAN WHEN AN ATTEMPT WAS MADE TO PASS THE GUIDEWIRE THROUGH THE THROMBUS. THE PHYSICIAN WITHDREW THE GUIDEWIRE AND OBSERVED A CRACK AT THE DISTAL TIP. 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 22046447 ↗MalfunctionMay 15, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE, ABNORMAL GUIDEWIRE MANIPULATION WAS OBSERVED DURING THE SUPER SELECTIVE CATHETERIZATION PROCESS. UPON WITHDRAWING THE SUBJECT GUIDEWIRE FOR INSPECTION, A SUSPECTED FRACTURE AT THE GUIDEWIRE'S DISTAL TIP WAS IDENTIFIED. THE SUBJECT GUIDEWIRE WAS POSITIONED IN THE MIDDLE CEREBRAL ARTERY (MCA) WHEN THE ISSUE OCCURRED. 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 22028832 ↗MalfunctionMay 6, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE FOR RECANALIZATION OF MIDDLE MCA (MIDDLE CEREBRAL ARTERY) OCCLUSION, THE PHYSICIAN USED THE SUBJECT GUIDEWIRE IN CONJUNCTION WITH A MICROCATHETER FOR SUPER SELECTIVE CATHETERIZATION OF THE VESSEL. DURING THE SUPER SELECTIVE CATHETERIZATION PROCESS, THE PHYSICIAN ROTATED THE PROXIMAL END OF THE SUBJECT GUIDEWIRE AND FOUND THAT THE DISTAL TIP OF THE SUBJECT GUIDEWIRE DID NOT FOLLOW THE ROTATION. UPON INSPECTION, IT WAS DISCOVERED THAT THE SUBJECT GUIDEWIRE HAD FRACTURED 5CM FROM THE TIP. 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 21971932 ↗MalfunctionApr 15, 2025Fracture; Fracture
IT WAS REPORTED THAT IN THE ANEURYSM EMBOLIZATION CASE, RESISTANCE WAS ENCOUNTERED WHEN THE SUBJECT GUIDEWIRE WAS DELIVERED INSIDE THE GUIDE CATHETER. UNDER THE X-RAY IT WAS FOUND THAT THE DISTAL TIP OF SUBJECT GUIDEWIRE WAS KINKED, AND WHEN IT WAS RETRIEVED, IT WAS FOUND THAT 10 CM FROM THE DISTAL END OF SUBJECT GUIDEWIRE WAS FRACTURED. THE SUBJECT GUIDEWIRE WAS REPLACED, AND 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 21840640 ↗MalfunctionApr 10, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT GUIDEWIRE GOT BROKEN WHEN BEING TAKEN OUT OF A BALLOON GUIDE CATHETER. 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 21816941 ↗MalfunctionApr 9, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING THE RECANALIZATION SURGERY FOR MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION, THE SUBJECT GUIDEWIRE WAS SELECTED TO GUIDE A MICROCATHETER THROUGH THE LESION. HOWEVER, DESPITE REPEATED ATTEMPTS OF PHYSICIAN, THE SUBJECT GUIDEWIRE COULD NOT SUCCESSFULLY NAVIGATE THROUGH THE LESION. THE IMAGING EXAMINATION REVEALED THE SIGNS OF STRETCHING AND FRACTURE APPROXIMATELY 3CM FROM THE DISTAL TIP OF THE GUIDEWIRE. THE PHYSICIAN REPLACED THE SUBJECT DEVICE, 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 21809312 ↗MalfunctionApr 1, 2025Fracture; Fracture
IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE BROKE APPROXIMATELY IN THE DISTAL THIRD DURING AN INTERVENTION IN THE MICROCATHETER. THE FRACTURED PART WAS REMOVED WITH STENT RETRIEVER AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21744390 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K053268. One submission often covers many models, so check the product and lot details in each record.
- Z-0869-2011 · Jun 7, 2010 · TerminatedBoston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Soft Pre Shaped; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is dis
- Z-0871-2011 · Jun 7, 2010 · TerminatedBoston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Soft Pre Shaped; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is dis
- Z-0872-2011 · Jun 7, 2010 · TerminatedBoston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distribute
- Z-0875-2011 · Jun 7, 2010 · TerminatedBoston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard Pre-Shaped; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is
- Z-0868-2011 · Jun 7, 2010 · TerminatedBoston Scientific brand Synchro 2 Guidewire, 0.14" 200 cm Soft. Boston Scientific; Made in: 2405 West Orton Circle, West Valley City, UT 84119 The Synchro guidewire series is int
- Z-0873-2011 · Jun 7, 2010 · TerminatedBoston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard Pre-Shaped; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is
- Z-0870-2011 · Jun 7, 2010 · TerminatedBoston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Soft; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by
- Z-0874-2011 · Jun 7, 2010 · TerminatedBoston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distribute
- Z-2068-2010 · Jun 3, 2010 · TerminatedBoston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, 200 cm x 10 cm, REF 50-810, UPN M001508100 Sterilized with ethylene oxide gas, Rx Only, Made in 2405 Ori
- Z-2071-2010 · Jun 3, 2010 · TerminatedBoston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, Pre-Shaped 300 cm x 10 cm, REF 50-815, UPN M001508150 Sterilized with ethylene oxide gas, Rx Only, Made
- Z-2069-2010 · Jun 3, 2010 · TerminatedBoston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, Pre-Shaped 200 cm x 10 cm, REF 50-811, UPN M001508110 Sterilized with ethylene oxide gas, Rx Only, Made
- Z-2070-2010 · Jun 3, 2010 · TerminatedBoston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, 300 cm x 10 cm, REF 50-814, UPN M001508140 Sterilized with ethylene oxide gas, Rx Only, Made in 2405 Ori
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
- 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
- SYNCHRO 2 M00326010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls79 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.