SYNCHRO 2 M00326010Recalls & reported problems
Stryker Corporation · Soft 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 soft hydrophilic guidewire is reported mostly breaking during procedures, sometimes leaving pieces in the patient and requiring successful completion with another device. There are 79 adverse event reports naming it, including 24 injuries, 55 malfunctions, and no deaths. The device also has 2 recalls: an open recall started April 2024 about PTFE coating damage from backloading through an optional introducer, and a closed recall from June 2018 about an incorrect guidewire outer diameter on labels.
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
- 79
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 04546540688729), received between Jan 27, 2017 and Jul 30, 2026 — classified as 24 injuries, 55 malfunctions.
The most frequently reported specific device problem is “Fracture” (47 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-0225-2020 · Root cause: Employee error · FDA record ↗
Most reported problems
Device problems
- Fracture47
- Peeled/Delaminated23
- Break10
- Flaked1
Patient problems
- No Clinical Signs, Symptoms or Conditions46
- No Consequences Or Impact To Patient17
- Foreign Body In Patient7
- Device Embedded In Tissue or Plaque4
- No Known Impact Or Consequence To Patient4
- No Patient Involvement2
- Ambulation or Postural Difficulties1
- Coma1
Recent adverse event reports
The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗InjuryOct 31, 2025Fracture; Fracture
IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE WAS USED DURING THROMBECTOMY IN THE DISTAL M2 SEGMENT. THE SUBJECT GUIDEWIRE SPRANG BACK ALONG WITH MICROCATHETER INTO PETROUS SEGMENT OF INTERNAL CAROTID ARTERY (ICA). DURING THE WITHDRAWAL THE TIP OF SUBJECT GUIDEWIRE BROKE AND WAS LOCATED AT THE PETROUS SEGMENT OF INTERNAL CAROTID ARTERY (ICA) UNDER X-RAY CONTROL. NO OBSTRUCTION OF BLOOD FLOW BY THE PIECE OF WIRE. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE PIECE OF WIRE USING A SNARE DEVICE AND STENT RETRIEVER WENT UNSUCCESSFUL. THE STENT WAS THEN INSERTED TO PRESS THE PIECE OF WIRE AGAINST THE WALL. THE PATIENT DID NOT SURVIVE THE INTERVENTION. THERE WAS A SURGICAL DELAY OF 4 HOURS DUE TO THE REPORTED EVENT. THE EXACT CAUSE OF DEATH IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 23438374 ↗MalfunctionJul 28, 2025Fracture; Fracture
IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE BECAME FRACTURED INSIDE THE MICROCATHETER. THE GUIDEWIRE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22624026 ↗MalfunctionMar 24, 2025Fracture; Fracture
THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE 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 21682663 ↗MalfunctionJan 15, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING CEREBRAL ANGIOGRAPHY AND MECHANICAL THROMBECTOMY, AN OCCLUSION WAS FOUND IN THE M1 SEGMENT. WHEN OPERATOR ATTEMPTED TO SELECTIVELY PASS THROUGH THE OCCLUDED AREA TO REACH THE DISTAL M2 SEGMENT, THE SUBJECT GUIDEWIRE HAD LOST ITS PUSHABILITY. THE SUBJECT GUIDEWIRE WAS WITHDRAWN, AND IT WAS DISCOVERED THAT IT'S DISTAL TIP HAD BROKEN INSIDE THE CATHETER. 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 21157972 ↗MalfunctionJan 10, 2025Fracture; Fracture
IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE HAD PROXIMAL BOND JOINTS BREAK DURING SIMULATED USE TESTING IN CHALLENGE SILICONE MODELS. THE GUIDEWIRES REMAINED INTACT AND DID NOT SEPARATE INTO PARTS. NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21126405 ↗MalfunctionSep 27, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING ANEURYSM EMBOLIZATION PROCEDURE, THE OPERATOR USED THE SUBJECT GUIDEWIRE TO GO THROUGH A MICROCATHETER. HOWEVER, FRICTION WAS ENCOUNTERED WHILE ROTATING THE SUBJECT GUIDEWIRE INSIDE THE MICROCATHETER. WHEN THE SUBJECT GUIDEWIRE WAS REMOVED FROM THE PATIENT'S ANATOMY, IT WAS FOUND FRACTURED AND STRETCHED. 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 20318258 ↗InjuryAug 6, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING AN MCA (MIDDLE CEREBRAL ARTERY) THROMBECTOMY CASE, WHILE PLACING THE SUBJECT GUIDEWIRE TO REACH THE TAIL OF THE ICA (INTERNAL CAROTID ARTERY), THE OPERATOR ENCOUNTERED A TORTUOUS VESSEL. TO NAVIGATE THIS, THE OPERATOR USED A TORQUE DEVICE TO ROTATE THE SUBJECT GUIDEWIRE PROXIMALLY AND ATTEMPTED SEVERAL TIMES TO PASS THE LESION. HOWEVER, THE SUBJECT GUIDEWIRE COULD NOT GO THROUGH THE LESION. WHEN THE OPERATOR TRIED TO WITHDRAW THE SUBJECT GUIDEWIRE TO ADJUST ITS POSITION, THE DISTAL 10 CM FRACTURED. THE OPERATOR THEN WITHDREW THE SUBJECT GUIDEWIRE DELIVERY WIRE AND USED A RETRIEVER TO REMOVE THE FRACTURED TIP. NO FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE PHYSICIAN REPLACED THE GUIDEWIRE WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19924215 ↗InjuryJul 25, 2024Fracture; Fracture
DURING AN ANEURYSM EMBOLIZATION PROCEDURE, THE OPERATOR PLACED A LONG SHEATH TO LEFT ICA (INTERNAL CAROTID ARTERY) PETROUS SEGMENT AND THEN PLACED DAC DEVICE (DISTAL ACCESS CATHETER ) WITH THE SUBJECT GUIDEWIRE TO PLACE THE DAC DEVICE TO CAVERNOUS SEGMENT. THE SUBJECT GUIDEWIRE WAS WITHDRAWN AND DELIVERED THE MICROCATHETER TIP TO GO INTO ANEURYSM AND THEN FILLED WITH COIL. THEN USED THE SECOND MICROCATHETER TO GO TO LEFT MCA (MIDDLE CEREBRAL ARTERY) DISTAL AND DEPLOYED A FLOW DIVERTER STENT. AFTER DEPLOYMENT, THE OPERATOR USED MICROCATHETER TO WORK WITH A SUBJECT GUIDEWIRE TO MESSAGE THE STENT INSIDE OF IT, AND THEN DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) SHOWED THE SUBJECT GUIDEWIRE WAS FRACTURED. THE RETRIEVER DEVICE WAS USED TO REMOVE THE FRACTURED GUIDEWIRE AND FINISHED THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19833548 ↗MalfunctionJul 18, 2024Fracture; Fracture
ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT GUIDEWIRE TIP WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19774347 ↗MalfunctionJun 26, 2024Peeled/Delaminated; Peeled/Delaminated
THE GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE SUBJECT GUIDEWIRE PTFE WAS SCRAPPED OFF ON SEVERAL PLACES. 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 19620119 ↗MalfunctionJun 26, 2024Peeled/Delaminated; Peeled/Delaminated
THE GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS PTFE (POLYTETRAFLUOROETHYLENE) WAS FOUND MISSING NEAR THE PROXIMAL END. 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 19618117 ↗InjuryApr 1, 2024Fracture; Fracture
IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE TIP IS TORN OFF IN THE PATIENT. IT WAS SUCCESSFULLY RECOVERED USING A SNARE. 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 19016251 ↗InjuryMar 19, 2024Fracture; Fracture
IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE SOFT TIP SNAPPED OFF IN A PATIENT AND HAD TO BE SNARED OUT. 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 18937335 ↗MalfunctionFeb 26, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A BODY PROCEDURE, SUBJECT GUIDEWIRE WAS BROKEN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18778941 ↗InjuryJan 16, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM CASE, PHYSICIAN USED SUBJECT GUIDEWIRE AND WHILE NAVIGATING IT TO THE DISTAL TARGET LOCATION, PHYSICIAN FOUND DISTAL TIP OF SUBJECT GUIDEWIRE BROKEN/FRACTURED. A SNARE DEVICE WAS USED TO REMOVE THE BROKEN SEGMENT OF THE SUBJECT GUIDEWIRE FROM THE PATIENT¿S BODY AS A MEDICAL INTERVENTION. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18516767 ↗InjuryJan 10, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING MCA (MIDDLE CEREBRAL ARTERY) THROMBECTOMY CASE, WHEN THE OPERATOR TRIED TO PLACE THE SUBJECT GUIDEWIRE TO DISTAL OF VESSEL AND DURING SUPER SELECTING OF THE SUBJECT GUIDEWIRE, FOR BETTER SUPPORTING THE OPERATOR ROTATED THE SUBJECT GUIDEWIRE, BUT THE DISTAL OF IT HAD NO REACTION. WHEN CHECKED, FOUND MID OF THE SUBJECT THE GUIDEWIRE FRACTURED. SOLITAIRE AB STENT WAS USED AS A MEDICAL INTERVENTION TO CAPTURE THE TIP OF THE SUBJECT GUIDEWIRE AND WITHDREW IT. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18489246 ↗MalfunctionJan 9, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING INTRACRANIAL ARTERY STENOSIS (ICAS) PROCEDURE THE OPERATOR DELIVERED THE SUBJECT GUIDEWIRE TO PASS THE LESION. WHEN THE OPERATOR TRIED TO DELIVER THE SUBJECT GUIDEWIRE TO GO INTO DISTAL OF VESSEL, THE DISTAL OF THE SUBJECT GUIDEWIRE DIDN'T REACT AS THE PROXIMAL DID. SO, THE OPERATOR FOUND THE SUBJECT GUIDEWIRE FRACTURED. 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 18476633 ↗MalfunctionDec 21, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING THE ACUTE LEFT MIDDLE CEREBRAL ARTERY OCCLUSION PROCEDURE, THE PHYSICIAN PREPARED TO DO IN SITU STENOSIS. PHYSICIAN USED A SLIM GUIDEWIRE AND MULTIPLE ANGIOGRAPHY CATHETER TO BRING DELIVERY CATHETER TO LEFT INTERNAL CAROTID ARTERY AND EXCHANGED WITH DISTAL ACCESS CATHETER. PHYSICIAN USED THE SUBJECT GUIDEWIRE TO BRING THE MICROCATHETER TO INTERNAL CAROTID ARTERY C6. HOWEVER, THE SUBJECT GUIDEWIRE COULD NOT BE MANIPULATED TO ADVANCE. DIGITAL SUBTRACTION ANGIOGRAPHY SHOWED THE TIP OF SUBJECT GUIDEWIRE FRACTURED IN C6, SO THE PHYSICIAN WITHDREW THE MICROCATHETER BUT COULDN'T SEE THE FRACTURED TIP. PHYSICIAN THEN ADVANCED THE DISTAL ACCESS CATHETER TO REACH C7 AND THE DIGITAL SUBTRACTION ANGIOGRAPHY SHOWED THE SUBJECT GUIDEWIRE TIP WAS INSIDE THE DISTAL ACCESS CATHETER. THE PHYSICIAN THEN WITHDREW THE DISTAL ACCESS CATHETER AND DELIVERY CATHETER OUT AND CONFIRMED THE TIP OF THE GUIDEWIRE WAS INSIDE DISTAL ACCESS 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 18380022 ↗MalfunctionOct 5, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING MCA (MIDDLE CEREBRAL ARTERY) M3 ANEURYSM EMBOLIZATION CASE, DISTAL OF THE SUBJECT GUIDEWIRE WAS FRACTURED DURING USE. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17882896 ↗MalfunctionOct 5, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING MCA (MIDDLE CEREBRAL ARTERY) M3 ANEURYSM EMBOLIZATION CASE. USED SUBJECT GUIDEWIRE TO DELIVER INSIDE MICROCATHETER. THE PATIENT'S VESSEL WAS QUITE THIN AND IT WAS HARD TO BE SUPER SELECTED AND THE OPERATOR ROTATED THE SUBJECT GUIDEWIRE AGAIN AND AGAIN AND THEN DISTAL OF THE SUBJECT GUIDEWIRE WAS FRACTURED DURING USE. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17882810 ↗MalfunctionJul 6, 2023Fracture; Fracture
DURING MANUFACTURER INTERNAL R&D SIMULATED USE TESTING IN A MMA SILICONE BENCH TOP FLOW MODEL WITH 0.5% LIQUINOX SOLUTION NOTICED SUBJECT GUIDEWIRE NOT RESPONDING TO TORQUE APPLIED BY THE USER. PULLED WIRE OUT OF THE MODEL AND NOTICED FRACTURE. THE ANATOMY WAS VERY TORTUOUS AND THERE WAS FRICTION/RESISTANCE ENCOUNTERED DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17264530 ↗MalfunctionApr 28, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE SUBJECT GUIDEWIRE WAS REINSERTED, A RESISTANCE WAS ENCOUNTERED WITHIN THE INTRODUCER SHEATH. THE SUBJECT GUIDEWIRE WAS RETRIEVED AND DURING VISUAL INSPECTION A FIBROUS MATERIAL WAS NOTED TO BE PEELING OFF. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16830809 ↗
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-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-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-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-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-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-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-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-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-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
- 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-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-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
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.