JETSTREAM XCRecalls & reported problems across all models

We found 2 models of JETSTREAM XC by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 550 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2018 and Aug 17, 2026 — classified as 54 injuries, 496 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (127 reports).

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

Most reported JETSTREAM XC problems

JETSTREAM XC models

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

• JETSTREAM™ XC 112266-001

  Catheter, peripheral, atherectomy
  288 reports
• JETSTREAM™ XC 112264-001

  Catheter, peripheral, atherectomy
  262 reports

Recent JETSTREAM XC adverse event reports

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

• MalfunctionAug 17, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50284734 ↗
• MalfunctionAug 13, 2026Suction Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50243496 ↗
• MalfunctionAug 6, 2026Suction Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161549 ↗
• MalfunctionJul 31, 2026Difficult to Remove; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50099816 ↗
• MalfunctionJul 13, 2026Entrapment of Device

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. A 2.1MM JETSTREAM? XC ATHERECTOMY CATHETER WAS SELECTED FOR USE IN A RIGHT LEG SUPERFICIAL FEMORAL ARTERY ATHERECTOMY AND STENTING PROCEDURE. THIS DEVICE WAS ADVANCED OVER A 300CM, 0.014IN NON-BOSTON SCIENTIFIC GUIDEWIRE. AFTER THE FIRST PASS WHEN TRYING TO RETRACT THE DEVICE IN REX MODE, IT BECAME STUCK ON THE GUIDEWIRE, AND THE ENTIRE SYSTEM HAD TO BE REMOVED. GUIDEWIRE ACCESS WAS LOST. AFTER REGAINING GUIDEWIRE ACCESS, THE PROCEDURE WAS ABLE TO BE COMPLETED. THE PROCEDURE WAS PROLONGED, BUT THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25807890 ↗
• MalfunctionJul 8, 2026Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE WAS ENTRAPPED WITH THE FILTER WIRE. A 2.4 MM JETSTREAM? XC CATHETER WAS USED WITH A FILTRAP FILTER WIRE DURING AN ENDOVASCULAR THERAPY PROCEDURE TO TREAT A 99% OCCLUDED SUPERFICIAL FEMORAL ARTERY LESION WITH MODERATE TORTUOSITY AND SEVERE CALCIFICATION. FOLLOWING ATHERECTOMY, THE JETSTREAM DEVICE BECAME STUCK WITH THE FILTER WIRE AND WAS DIFFICULT TO WITHDRAW. THIS REQUIRED FORCEFUL REMOVAL AND THE JETSTREAM CATHETER AND FILTER WIRE WERE REMOVED TOGETHER AS ONE UNIT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25749371 ↗
• MalfunctionJun 29, 2026Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE. A 2.4 MM JETSTREAM? XC ATHERECTOMY CATHETER WAS USED DURING A SUPERFICIAL FEMORAL ARTERY ANGIOGRAM PROCEDURE TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION WITH 60% STENOSIS. FOLLOWING SUCCESSFUL USE OF THE CATHETER, THE DEVICE COULD NOT BE REMOVED AND WAS STRETCHED PROXIMAL TO THE INFUSION PORTS. THE CATHETER WAS MANUALLY REMOVED BY PULLING FROM THE PATIENT IN ONE PIECE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659545 ↗
• MalfunctionMay 20, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT CONTAMINATION OCCURRED. A JETSTREAM? XC CATHETER WAS SELECTED FOR A LOWER EXTREMITIES (LE) ANGIOGRAM TO TREAT PERIPHERAL ARTERY DISEASE (PAD). WHEN THE OUTER PACKAGE WAS OPENED, HOWEVER, IT WAS NOTED THAT THE INNER COVER WAS NOT FULLY SEALED, COMPROMISING THE DEVICE STERILITY. THE DEVICE WAS NOT USED INSIDE OF THE PATIENT. AN ALTERNATE JETSTREAM DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234727 ↗
• MalfunctionApr 27, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT THE STERILE PACKAGING SEAL WAS INCOMPLETE AND CONTAMINATED. THE TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. A JETSTREAM? XC CATHETER WAS CHOSEN FOR AN ANGIOGRAM PROCEDURE IN THE LOWER EXTREMITY TO TREAT PERIPHERAL ARTERY DISEASE (PAD) INSIDE OF THE PATIENT. DURING PREPARATION PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE INNER PACKAGING OF THE DEVICE WAS NOT FULLY SEALED AND CONTAMINATED; HOWEVER, THERE WAS NO FOREIGN MATERIAL LOCATED IN THE PACKAGING. A DIFFERENT DEVICE OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001072 ↗
• MalfunctionApr 15, 2026Suction Failure

  IT WAS REPORTED THAT FAILURE TO EVACUATE OCCURRED. THE 90% STENOSED, MILDLY TORTUOUS, AND SEVERELY CALCIFIED TARGET LESION WAS LOCATED IN THE RIGHT SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A JETSTREAM? XC CATHETER WAS SELECTED FOR AN ENDOVASCULAR THERAPY (EVT) PROCEDURE TO TREAT INTERMITTENT CLAUDICATION IN THE RIGHT SFA. DURING THE PROCEDURE, LOSS OF ASPIRATION OCCURRED. THE DEVICE WAS RE-PRIMED; HOWEVER, THIS DID NOT RESOLVE THE LOSS OF ASPIRATION ISSUE. A DIFFERENT DEVICE OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888493 ↗
• InjuryApr 1, 2026Failure to Advance; Device-Device Incompatibility; Noise, Audible

  IT WAS REPORTED THAT ADDITIONAL INTERVENTION WAS REQUIRED IN THIS EVENT. THE 95% STENOSED, OCCLUDED VESSEL WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A JETSTREAM? XC CATHETER WAS SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE INTENDED TO TREAT THE OCCLUDED VESSEL. DURING ADVANCEMENT TOWARD THE TARGET LESION, THE DEVICE WAS UNABLE TO PROGRESS AS EXPECTED AND AN AUDIBLE NOISE WAS NOTED. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM THE PATIENT. UPON REMOVAL, A PRE-EXISTING UNKNOWN-BRAND COVERED STENT WAS NOTED TO BE ATTACHED TO THE DEVICE. A THROMBECTOMY PROCEDURE WAS ATTEMPTED TO ADDRESS THE RESULTING CONDITION, AND A BYPASS PROCEDURE WAS THEN PERFORMED TO RESTORE BLOOD FLOW. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) AFTERWARDS FOR RECOVERY.

  Patient problems: Reduced Blood Flow

  MAUDE report 24758121 ↗
• MalfunctionMar 26, 2026Difficult to Remove; Mechanical Jam

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED WITH THE DEVICE. A 2.4MM JETSTREAM XC DEVICE WAS SELECTED FOR A POPLITEAL ANGIOGRAM TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA) THROMBUS OCCLUSION. DURING THE PROCEDURE, SEVERAL PASSES WERE MADE WITH JETSTREAM WITHOUT ISSUE. WHEN REMOVING THE JETSTREAM DEVICE, DIFFICULTY WAS ENCOUNTERED WHEN REMOVING IT OVER THE WIRE. THE DEVICE WAS FULLY REMOVED FROM THE GUIDEWIRE, AND ANOTHER ATTEMPT WAS MADE TO PUT THE JETSTREAM BACK ON THE GUIDEWIRE AND INTO THE PATIENT. THE DEVICE COULD NOT BE RELOADED ONTO THE GUIDEWIRE BEYOND 1CM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT A BOSTON SCIENTIFIC THRUWAY GUIDEWIRE WAS THE GUIDEWIRE INVOLVED IN THIS EVENT. IN ADDITION, THE 100% STENOSED TARGET LESION WAS SEVERELY CALCIFIED, AND MODERATELY TORTUOUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24707061 ↗
• MalfunctionMar 12, 2026Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED MATERIAL SEPARATION OCCURRED WITH THE DEVICE. THE 70% STENOSED, MILDLY CALCIFIED AND TORTUOUS LESION WAS LOCATED IN THE PERIPHERAL ARTERY. A JETSTREAM? XC WAS SELECTED FOR A LOWER EXTREMITY ANGIOGRAM PROCEDURE TO TREAT PERIPHERAL ARTERY DISEASE (PAD). DURING THE PROCEDURE, A SEGMENT OF THE OUTER TUBING MATERIAL OF THE DEVICE SEPARATED. THE PORTION OF THE DEVICE WAS OUTSIDE OF THE PATIENT'S BODY AT THE TIME OF THE MATERIAL SEPARATION. THE DEVICE WAS REMOVED INTACT. A DIFFERENT DEVICE OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586447 ↗
• MalfunctionMar 11, 2026Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. SEVERE CALCIFICATION WAS ALSO NOTED FROM THE MID TO DISTAL PART OF THE SUPERFICIAL FEMORAL ARTERY. A 2.4MM JETSTREAM XC CATHETER WAS SELECTED FOR AN ENDOVASCULAR THERAPY PROCEDURE. AFTER PERFORMING COMPLETE ABLATION WITH A JETSTREAM SC ATHERECTOMY CATHETER, THE CATHETER WAS REPLACED WITH THE 2.4MM JETSTREAM XC CATHETER. WHILE PERFORMING ABLATION FROM THE PROXIMAL TO MID AND DISTAL SUPERFICIAL FEMORAL ARTERY, IT SUDDENLY GOT STUCK WITH NON-BOSTON SCIENTIFIC FILTER WIRE AND COULD NOT BE ADVANCED. BOTH THE FILTER WIRE AND JETSTREAM CATHETER WERE REMOVED TOGETHER. THE GUIDEWIRE WAS REPLACED WITH THRUWAY 0.014 300CM, AND THE PROCEDURE WAS CONTINUED USING A NEW JETSTREAM CATHETER OF THE SAME SIZE; THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24576396 ↗
• MalfunctionMar 4, 2026Entrapment of Device; Deformation Due to Compressive Stress

  IT WAS REPORTED THE DEVICE BECAME KINKED AND STUCK ON THE GUIDEWIRE. THE MILDLY CALCIFIED AND MODERATELY TORTUOUS TARGET AREA WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A JETSTREAM XC DEVICE WAS SELECTED FOR AN ATHERECTOMY PROCEDURE IN THE SFA TO TREAT THE TARGET OCCLUSION. DURING THE PROCEDURE THE JETSTREAM XC BECAME KINKED, DISTAL TO THE INFUSION PORT ON THE DEVICE, WHEN ATTEMPTING TO PASS THROUGH A BIFURCATION. THEN, THE DEVICE BECAME STUCK ON A NON-BOSTON SCIENTIFIC GUIDEWIRE. THE JETSTREAM XC AND NON-BOSTON SCIENTIFIC GUIDEWIRE HAD TO BE REMOVED TOGETHER AS ONE UNIT. A DIFFERENT DEVICE WITH A NEW GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506581 ↗

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