SYNCHRO 2 M00326510Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 04546540688781), received between Jan 31, 2017 and Sep 2, 2026 — classified as 16 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Fracture” (28 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.

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

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50555072 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE FOR INTRACRANIAL ARTERIAL STENOSIS, THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO DELIVER THE SUBJECT GUIDEWIRE THROUGH THE LESION SITE IN THE M1 SEGMENT OF THE MCA BUT FAILED. AFTER SEVERAL ATTEMPTS, THE TIP OF THE SUBJECT GUIDEWIRE BROKE OFF. 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 23843161 ↗
• MalfunctionSep 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PHYSICIAN USED A 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 GUIDEWIRE HAD DEFORMED. THE PHYSICIAN REPLACED THE GUIDEWIRE WITH A SUBJECT 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 A FRACTURE NOTED TO THE NITINOL TUBING OF THE SUBJECT GUIDEWIRE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23072303 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS USING THE SUBJECT GUIDEWIRE, THE TIP OF THE SUBJECT GUIDEWIRE ADHERED TO THE INTIMA OF THE BLOOD VESSEL. AFTER WITHDRAWING THE GUIDEWIRE OUT OF THE BODY, THE PHYSICIAN FOUND THAT THE GUIDEWIRE WAS ATTACHED WITH INTIMAL TISSUE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Perforation

  MAUDE report 22983082 ↗
• MalfunctionAug 20, 2025Fracture; Fracture

  THE SUBJECT GUIDEWIRE WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE SUBJECT GUIDEWIRE NITINOL TUBING WAS NOTED TO BE 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 22846996 ↗
• MalfunctionAug 6, 2025Fracture; Peeled/Delaminated; Fracture; Peeled/Delaminated

  IT WAS REPORTED THAT AFTER THE GUIDEWIRE AND MICROCATHETER WERE DELIVERED INTO POSITION, THE SUBJECT GUIDEWIRE WAS USED FOR EXCHANGE AND TO DELIVER A BALLOON CATHETER. DURING THE INTRODUCTION OF THE BALLOON CATHETER, THE TIP OF THE SUBJECT GUIDEWIRE BROKE IN THE VESSEL, LEAVING THE GUIDEWIRE FRAGMENT INSIDE THE CEREBRAL BLOOD VESSEL. SUBSEQUENTLY, THE PHYSICIAN USED A RETRIEVER STENT TO REMOVE THE GUIDEWIRE FRAGMENT. AFTER A LONG TIME, THE OPERATOR FINALLY DECIDED NOT TO CONTINUE TO TREAT THE OCCLUDED VESSEL AND FINISH THE PROCEDURE. THERE WAS A SURGICAL DELAY OF 30 MINUTES DUE TO THE REPORTED EVENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22724033 ↗
• MalfunctionJul 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE DELIVERY OF THE SUBJECT GUIDEWIRE TO THE DISTAL END OF THE M1 SEGMENT, THE PHYSICIAN SLIGHTLY TWISTED AND CONTROLLED THE GUIDEWIRE. THE PHYSICIAN NOTICED SIGNS OF BREAKAGE IN THE MIDDLE SECTION OF THE SUBJECT 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 22681500 ↗
• MalfunctionJul 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING BASILAR ARTERY (BA) OCCLUSION CASE, WHEN THE SUBJECT GUIDEWIRE WAS USED TO GUIDE THE MICROCATHETER THROUGH LESION, EVEN AFTER REPEATED ATTEMPTS WITH THE SUBJECT GUIDEWIRE IT FAILED TO SUCCESSFULLY CROSS THE LESION. UPON REMOVING, IT WAS OBSERVED THAT THE SUBJECT GUIDEWIRE TIP WAS KINKED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT. THE SUBJECT GUIDEWIRE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT GUIDEWIRE DISTAL TIP WAS FOUND BROKEN DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391045 ↗
• MalfunctionJun 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) WAS USED AS A REPLACEMENT DEVICE FOR THE INITIALLY USED GUIDEWIRE. HOWEVER, THE SUBJECT DEVICE COULD NOT CROSS THE LESION. AFTER A WHILE OF CONTINUOUS ATTEMPTS, THE FLUOROSCOPY REVEALED A FRACTURE ON THE SUBJECT DEVICE. THE PHYSICIAN WITHDREW THE SUBJECT DEVICE AND FOUND THE DISTAL TIP TO BE 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 22181350 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING STENOSIS IN THE LEFT MIDDLE CAROTID ARTERY (MCA) PROCEDURE, THE OPERATOR ESTABLISHED ACCESS USING A LONG SHEATH. NEXT, THE OPERATOR USED THE SUBJECT GUIDEWIRE ALONG WITH THE BALLOON GUIDE CATHETER TO PAST THE STENOTIC LESION. DURING THIS PROCESS, THE GUIDEWIRE INADVERTENTLY PERFORATED THE VESSEL, AND EXTRAVASATION OF CONTRAST AGENT WAS OBSERVED UNDER ANGIOGRAPHY. FOLLOWING THE INCIDENT, BALLOON INFLATION WAS USED TO APPLY PRESSURE AT THE SITE OF INJURY, AND SUBSEQUENT ANGIOGRAPHY SHOWED NO FURTHER CONTRAST AGENT EXTRAVASATION. THE INTERVENTIONAL PROCEDURE WAS THEN TERMINATED, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). CURRENTLY, THE PATIENT REMAINS IN A COMA.

  Patient problems: Coma; Perforation of Vessels

  MAUDE report 21159630 ↗
• InjuryDec 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE TO ADDRESS MIDDLE CEREBRAL ARTERY (MCA) M2 STENOSIS, A LONG SHEATH WAS USED IN CONJUNCTION WITH A MIDDLE CATHETER TO ESTABLISH ACCESS. USED THE SUBJECT GUIDEWIRE TO WORK WITH A NON-STRYKER MICROCATHETER TO PASS THE STENOSIS. THE OPERATOR PUSHED THE PROXIMAL END OF THE SUBJECT GUIDEWIRE AND CHECKED UNDER DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) TO CONFIRM THAT THE TIP HAD NOT MOVED. WHILE ATTEMPTING TO WITHDRAW THE SUBJECT GUIDEWIRE, THE DISTAL END WAS STILL NOT MOVING. THE OPERATOR LOCKED THE MICROCATHETER AND THE PROXIMAL END OF THE SUBJECT GUIDEWIRE, WITHDRAWING THE SYSTEM TOGETHER INTO THE MIDDLE CATHETER BEFORE FULLY REMOVING IT. WHEN CHECKED, IT WAS DISCOVERED THAT THE TIP OF THE SUBJECT GUIDEWIRE HAD FRACTURED. THE FRACTURED TIP WAS LEFT IN THE DISTAL M2 STENOSIS. A RETRIEVER DEVICE WAS USED AS A MEDICAL INTERVENTION TO REMOVE THE FRACTURED TIP, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FRAGMENTS LEFT INSIDE THE PATIENT. NO CLINICAL CONSEQUENCES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21022665 ↗
• MalfunctionDec 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE WAS USED FOR BA (BASILAR ARTERY) STENOSIS CASE. WHEN THE SUBJECT GUIDEWIRE WAS ADJUSTED FOR SEVERAL TIMES BECAUSE OF THE TORTUOUS VESSEL, THE TIP OF THE SUBJECT GUIDEWIRE WAS KINKED. AFTER REMOVING THE SUBJECT GUIDEWIRE OUT FROM PATIENT¿S BODY, THE KINKED POSITION WAS FRACTURED (NOT COMPLETELY). SINCE SOME FORCE WAS APPLIED TO PULL OUT THE SUBJECT GUIDEWIRE, THE FRACTURED SECTION WAS STRETCHED. THE SUBJECT GUIDEWIRE WAS REPLACED WITH A NEW SAME DEVICE AND CONTINUED THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019772 ↗
• MalfunctionNov 6, 2024Fracture; Fracture

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE GUIDEWIRE (SUBJECT DEVICE) 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 20624084 ↗
• MalfunctionSep 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE WAS USED WITH OTHER DEVICES IN RIGHT VA ACCUTE OCCLUSION CASE. WHEN PASSING THE SUBJECT GUIDEWIRE THROUGH THE LESION, THE OPERATOR CHECKED UNDER DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) SHOWED THE TIP 15CM OF THE SUBJECT GUIDEWIRE WAS FRACTURED. THE OPERATOR PULLED THE SUBJECT GUIDEWIRE AND MICROCATHETER OUT AND REPLACED THE SUBJECT GUIDEWIRE WITH ANOTHER ONE. THE BALLOON CATHETER WAS USED TO DILATE THE LESION AND COMPLETED THE PROCEDURE SUCCESSFULLY. THE FRACTURED TIP OF THE SUBJECT GUIDEWIRE WAS LEFT INSIDE THE PATIENT'S BODY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO AN UN RETRIEVED DEVICE FRAGMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20190604 ↗
• MalfunctionAug 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE WAS USED WITH OTHER DEVICES AT LEFT INTERNAL CAROTID ARTERY OA STENOSIS DILATION AND STENTING CASE. WHEN PREPARED TO DELIVER THE STENT ALONG WITH THE SUBJECT GUIDEWIRE, BUT THE STENT WAS NOT ABLE TO PASS THE STENOSIS, AND THE OPERATOR FINALLY DECIDED TO FINISH THE PROCEDURE. UNDER DIGITAL SUBTRACTION ANGIOGRAPHY (DSA), THE OPERATOR FOUND THE TIP 7CM OF THE SUBJECT GUIDEWIRE WAS LEFT AT THE STENOSIS LOCATION AS THE SUBJECT GUIDEWIRE MIGHT BE FRACTURED DURING USE. DSA SHOWED THE VESSEL FLOW WAS IMPROVED AND THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT. THE CURRENT CONDITION OF THE PATIENT IS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20078920 ↗
• InjuryJul 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING RIGHT INTERNAL CAROTID ARTERY ICA SEVERE STENOSIS STENTING CASE, SUBJECT GUIDEWIRE WAS USED TO PLACE DRUG-ELUTING STENT. THE OPERATOR TRIED SEVERAL TIMES, BUT THE STENT COULD NOT PASS THE LESION, SO THE OPERATOR DECIDED TO KEEP THE SUBJECT GUIDEWIRE AND WITHDREW THE STENT OUT. THERE WAS FRICTION/RESISTANCE ENCOUNTERED WHEN THE GUIDE WIRE PASSES THROUGH THE LESION. WHEN MANIPULATING THE SUBJECT GUIDEWIRE AGAIN, THE OPERATOR CHECKED UNDER DIGITAL SUBTRACTION ANGIOGRAPHY DSA AND FOUND 6MM FROM TIP OF THE SUBJECT GUIDEWIRE WAS FRACTURED. SO, HE WITHDREW THE SUBJECT GUIDEWIRE AND TIP WAS LEFT INSIDE THE VESSEL CLOSE TO THE PROXIMAL OF LESION. TRIED TO TAKE IT OUT USING A STENT RETRIEVER BUT FAILED. THEN THE OPERATOR FINISHED THE PROCEDURE. AFTER THE PROCEDURE THE PATIENT RECOVERED AND NO OTHER ANOMALY. PLANNED TO ARRANGE ANOTHER SURGERY TO REMOVE FRACTURED FRAGMENT OF SUBJECT GUIDEWIRE. THERE IS NO REDUCTION IN THE BLOOD FLOW DUE TO AN UNRETRIEVED DEVICE FRAGMENT LEFT IN THE VASCULATURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19700773 ↗
• MalfunctionMay 20, 2024Fracture; Fracture

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE GUIDEWIRE (SUBJECT DEVICE) DISTAL TIP WAS BROKEN/FRACTURED DURING USE. 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 19355610 ↗
• InjuryMay 1, 2024Fracture; Fracture

  IT WAS REPORTED DURING THE PROCEDURE THE DISTAL SECTION OF THE SUBJECT GUIDEWIRE FRACTURED DURING MANIPULATION OF THE WIRE IN THE DISTAL VASCULATURE. THE BROKEN FRAGMENTS WERE NOT REMOVED FROM THE PATIENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19222716 ↗
• InjuryNov 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE NEUROVASCULAR PROCEDURE, THE GUIDEWIRE (SUBJECT DEVICE) WAS PASSED ABOVE THE STENOSIS AND BALLOON ANGIOPLASTY WAS ATTEMPTED. HOWEVER IT WAS NOTED THAT THE GUIDEWIRE (SUBJECT DEVICE) DID NOT RESPOND TO ROTATION. THE PROXIMAL PORTION OF THE GUIDEWIRE (SUBJECT DEVICE) WAS REMOVED AND IT WAS OBSERVED THE DISTAL SECTION OF THE GUIDEWIRE (SUBJECT DEVICE) REMAINED IN THE LEFT MCA (MIDDLE CEREBRAL ARTERY) AND LEFT ICA (INTERNAL CAROTID ARTERY). THIS SECTION OF THE GUIDEWIRE (SUBJECT DEVICE) WAS REMOVED WITH A 4 MM EXTRACTION LOOP, WITHOUT COMPLICATIONS. THE PROCEDURE WAS PROLONGED BY ABOUT 1 HOUR. 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 18237913 ↗
• MalfunctionJul 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE THE SUBJECT GUIDEWIRE COULD NOT PASS THE ICA (INTERNAL CAROTID ARTERY) SIPHON SECTION TO DISTAL OCCLUSION. THE SUBJECT GUIDEWIRE WAS RETRIEVED AND IT WAS FOUND THAT FRACTURED AT TIP WITH CORE WIRE CONNECTED. 70 PERCENTAGE STENOSIS AND CALCIFICATION AT THE LESION WAS REPORTED. 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 17264476 ↗
• MalfunctionMay 15, 2023Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE PTFE ( POLYTETRAFLUOROETHYLENE) COATING OF THE SUBJECT GUIDEWIRE WAS PEELING FROM THE PROXIMAL END. 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 16931199 ↗
• InjuryJan 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS TRYING TO MANIPULATE THE GUIDEWIRE (SUBJECT DEVICE) INSIDE THE MICROCATHETER HE NOTICED THAT THE GUIDEWIRE (SUBJECT DEVICE) WAS NOT MOVING DISTALLY AND PROXIMALLY AT ALL AND WHEN HE REMOVED THE GUIDEWIRE (SUBJECT DEVICE) FROM THE CATHETER HE FOUND THAT DISTAL END OF THE GUIDEWIRE (SUBJECT DEVICE) GOT BREAK ON ITS OWN AND ONLY PROXIMAL END CAME OUT AND DISTAL END GOT LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. UPDATE: RECEIVED ADDITIONAL INFORMATION ON 19-JAN-2020 STATED THAT PATIENT IS ON DUAL ANTIPLATELET.

  Patient problems: Foreign Body In Patient

  MAUDE report 16199866 ↗

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-0874-2011 · Jun 7, 2010 · Terminated
  Boston 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-0873-2011 · Jun 7, 2010 · Terminated
  Boston 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-0868-2011 · Jun 7, 2010 · Terminated
  Boston 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 · Terminated
  Boston 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-0875-2011 · Jun 7, 2010 · Terminated
  Boston 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-0870-2011 · Jun 7, 2010 · Terminated
  Boston 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-0871-2011 · Jun 7, 2010 · Terminated
  Boston 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 · Terminated
  Boston 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-2071-2010 · Jun 3, 2010 · Terminated
  Boston 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 · Terminated
  Boston 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 · Terminated
  Boston 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 · Terminated
  Boston 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