JETSTREAM SCRecalls & reported problems across all models

We found 2 models of JETSTREAM SC by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 63 adverse event reports in the FDA's MAUDE database, received between Oct 17, 2018 and Aug 28, 2026 — classified as 1 death, 23 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (26 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 SC problems

JETSTREAM SC models

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

• JETSTREAM™ SC 112262-001

  Catheter, peripheral, atherectomy
  1 death32 reports
• JETSTREAM™ SC 112260-001

  Catheter, peripheral, atherectomy
  31 reports

Recent JETSTREAM SC adverse event reports

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

• MalfunctionAug 28, 2026Mechanical Problem; Nonstandard Device; Suction Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50508406 ↗
• MalfunctionJul 2, 2026Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE BECAME ENTRAPPED WITH THE GUIDEWIRE. A 1.6 MM JETSTREAM? SC CATHETER WAS USED DURING AN ENDOVASCULAR THERAPY PROCEDURE TO TREAT A SEVERELY CALCIFIED, MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY WITH 100% STENOSIS. AFTER SUCCESSFUL ATHERECTOMY, RESISTANCE WAS ENCOUNTERED DURING DEVICE REMOVAL DUE TO THE CATHETER BECAME STUCK ON A THRUWAY 0.014 GUIDEWIRE. THE DEVICE AND GUIDEWIRE WERE WITHDRAWN TOGETHER AND GRADUALLY REMOVED FROM THE PATIENT. ONCE OUTSIDE THE PATIENT, THE JETSTREAM CATHETER WAS ABLE TO BE REMOVED FROM THE GUIDEWIRE BY APPLYING SIGNIFICANT FORCE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25692958 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A DISTAL EMBOLISM OCCURRED THAT REQUIRED ADDITIONAL INTERVENTION. THE 100% STENOSED, MODERATELY TORTUOUS, AND SEVERELY CALCIFIED VESSEL WAS LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). A JETSTREAM? SC AND JETSTREAM XC CATHETERS WERE SELECTED FOR USE IN AN ENDOVASCULAR THERAPY (EVT) PROCEDURE TO TREAT LOWER EXTREMITY ARTERIAL DISEASE (LEAD). DURING THE PROCEDURE, BOTH OF THE DEVICES FUNCTIONED AS EXPECTED. THE PATIENT EXPERIENCED A DISTAL EMBOLISM THAT REQUIRED ADDITIONAL INTERVENTION. THE ADDITIONAL INTERVENTION INCLUDED EMBOLIZATION IN THE ARTERIAL TIBIAL ARTERY (ATA) AND ASPIRATION TO REMOVE THE DEBRIS. THE DEBRIS WAS SUCCESSFULLY RETRIEVED, AND THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE.

  Patient problems: Embolism/Embolus

  MAUDE report 24834513 ↗
• MalfunctionFeb 12, 2026Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK ON THE EMBOLIC PROTECTION DEVICE (EPD). A JETSTREAM SC CATHETER, 1.85MM, WAS SELECTED FOR USE TO TREAT STENOSIS IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET LESION WAS REPORTED TO BE 100% STENOSED WITH SEVERE CALCIFICATION. THE JETSTREAM WAS USED IN CONJUNCTION WITH A NON-BOSTON SCIENTIFIC EPD. AFTER USING THE JETSTREAM FOR ABOUT 4.5 MINUTES, REMOVAL WAS ATTEMPTED, HOWEVER, THE DEVICE BECAME ENTRAPPED ON THE EPD. BOTH THE JETSTREAM AND EPD 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 24327778 ↗
• MalfunctionDec 8, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED AND NON-TORTUOUS SUPERFICIAL FEMORAL ARTERY. A 1.85MM JETSTREAM SC CATHETER WAS SELECTED FOR THE ATHERECTOMY PROCEDURE TO TREAT THE LOWER EXTREMITY ARTERIAL DISEASE. A SAME-SIDE ANTEGRADE APPROACH WAS USED. A NON-BOSTON SCIENTIFIC (BSC) SHEATH WAS PLACED, AND A TOURNIQUET WAS APPLIED AT THE KNEE. HOWEVER, DUE TO CALCIFICATION, BLOOD FLOW COULD NOT BE OCCLUDED, SO A NON-BSC EMBOLIC PROTECTION DEVICE WAS USED. WHEN THE JETSTREAM WAS USED FOR CUTTING AND THEN WITHDRAWN, THE NON-BSC EMBOLIC PROTECTION DEVICE AND THE JETSTREAM BECAME ENTRAPPED AND COULD NOT BE REMOVED. WHILE TRACTION WAS APPLIED, THE FILTER PORTION OF THE NON-BSC EMBOLIC PROTECTION DEVICE BECAME SEPARATED. AFTER THE JETSTREAM WAS REMOVED, THE SEPARATED PORTION WAS SAFELY RETRIEVED WITH AN INTRAVASCULAR FORCEPS. THE PROCEDURE WAS COMPLETED WITHOUT ISSUES, AND THE PHYSICIAN REPORTED THAT THE PATIENT'S CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23747897 ↗
• MalfunctionDec 5, 2025Fluid/Blood Leak; Noise, Audible; Suction Failure; Fluid/Blood Leak; Noise, Audible; Suction Failure

  IT WAS REPORTED THAT A LOSS OF ASPIRATION OCCURRED. THE TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS 95% STENOSED, SEVERELY CALCIFIED AND MODERATELY TORTUOUS. A 1.85MM JETSTREAM SC ATHERECTOMY CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THERE WAS NO SUCTION INSIDE THE PATIENT, ONLY AIR RETURNED. LIQUID WAS OBSERVED TO BE LEAKING FROM THE CONTROL POD. THE CONTROL POD ALSO MADE A HIGH-PITCH NOISE WHEN ROTATING. THE DEVICE WAS REPLACED WITH A NEW DEVICE, SAME MODEL TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728520 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VESSEL RUPTURE OCCURRED, REQUIRING AN ADDITIONAL DEVICE. A 1.85MM JETSTREAM SC CATHETER WAS SELECTED FOR AN ENDOVASCULAR THERAPY PROCEDURE IN A SUPERFICIAL FEMORAL ARTERY (SFA). THE SFA CALCIFIED LESION WAS ABLATED USING THE JETSTREAM, WHICH RESULTED IN VASCULAR RUPTURE. THE DEVICE WAS ABLE TO BE REMOVED AS USUAL. AFTER THAT, A NON-BOSTON SCIENTIFIC STENT WAS IMPLANTED, AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED.

  Patient problems: Perforation of Vessels

  MAUDE report 23647197 ↗
• MalfunctionNov 7, 2025Suction Problem; Noise, Audible; Suction Failure; Suction Problem; Noise, Audible; Suction Failure

  IT WAS REPORTED THAT FAILURE TO EVACUATE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 1.85MM JETSTREAM SC CATHETER WAS SELECTED FOR AN ENDOVASCULAR THROMBECTOMY (EVT) PROCEDURE TO TREAT PERIPHERAL ARTERY DISEASE (PAD). DURING THE PROCEDURE, A NOISE WAS HEARD, AND LOSS OF ASPIRATION OCCURRED. AFTER, PRIMING WAS PERFORMED BUT NOT COULD NOT BE COMPLETED SUCCESSFULLY. 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 23496823 ↗
• MalfunctionOct 15, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THE DEVICE BECAME STUCK ON A NON-BOSTON SCIENTIFIC GUIDEWIRE. A 1.85MM JETSTREAM SC CATHETER WAS SELECTED FOR A PROCEDURE TO TREAT A 90% STENOSED, MODERATELY TORTUOUS, AND SEVERELY CALCIFIED TARGET REGION WITH INTERMITTENT CLAUDICATION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). AFTER THE 1.85MM JETSTREAM SC CATHETER WAS USED IN COMBINATION WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE, THE 1.85MM JETSTREAM SC CATHETER BECAME STUCK ON THE NON-BOSTON SCIENTIFIC GUIDEWIRE. 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 23304190 ↗
• MalfunctionSep 11, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT STERILITY WAS COMPROMISED. THIS 1.85MM JETSTREAM SC HAD NO DAMAGE TO THE OUTER BOX; HOWEVER, THE PACKAGING SEAL WAS BROKEN, SO THE CONTENTS COULD BE TAKEN OUT. IT WAS REPORTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026752 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VESSEL DISSECTION PERFORATION, AND AN ADDITIONAL DEVICE WAS REQUIRED. A 1.85MM JETSTREAM SC CATHETER WAS CHOSEN TO TREAT A 95% STENOSED, MODERATELY TORTUOUS AND CALCIFIED TARGET LESION WITH INTERMITTENT CLAUDICATION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). PRIOR TO THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AND VESSEL OCCLUSION. DURING THE PROCEDURE, 1.85MM JETSTREAM SC CATHETER FUNCTIONED AS EXPECTED; HOWEVER, A VESSEL PERFORATION OCCURRED THAT RESULTED FROM CUTTING TOO CLOSE TO THE BLOOD VESSEL WALL. THE PERFORATION RESULTED IN INTERNAL BLEEDING, AND A NON-BOSTON SCIENTIFIC STENT WAS PLACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF A DIFFERENT MODEL. THERE WERE NO FURTHER PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 22952388 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A SYMPOSIUM PRESENTATION AT ANNUAL MEETING OF THE JAPANESE ASSOCIATE OF CARDIOVASCULAR INTERVENTION AND THERAPEUTICS (CVIT2025) THAT THE INCIDENCE OF DISTAL EMBOLISM DURING PROCEDURES USING JETSTREAM ATHERECTOMY SYSTEMS AND (B)(4) IN THE CASES STUDIED FOR THE PRESENTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED THROUGH GOOD FAITH EFFORT ATTEMPTS; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Embolism/Embolus

  MAUDE report 22805367 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A PRESENTATION AT THE (B)(6) THAT THE INCIDENCE OF DISTAL EMBOLISM IN THE JET-FORWARD STUDY WAS (B)(4). JETSTREAM ATHERECTOMY CATHETERS HAVE BEEN SELECTED FOR ATHERECTOMY PROCEDURES TO TREAT HEAVILY CALCIFIED LESIONS. OF THE PROCEDURES ANALYZED IN THE JET-FORWARD STUDY PRESENTATION AT THE (B)(6) RESEARCH SYMPOSIUM, DISTAL EMBOLISM WAS REPORTED TO HAVE OCCURRED AT A (B)(4) INCIDENCE RATE. THERE WAS NO REPORTED INFORMATION REGARDING INTERVENTIONS OR THE PATIENT STATUSES FOLLOWING THE PROCEDURES.

  Patient problems: Embolism/Embolus

  MAUDE report 22800491 ↗
• MalfunctionJun 25, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THE DEVICE BECAME STUCK ON A THRUWAY GUIDEWIRE. THE 90% STENOSED, AND MODERATELY TORTUOUS TARGET LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) TO TREAT PERIPHERAL ARTERY DISEASE (PAD). A 1.85 MM JETSTREAM SC CATHETER WAS SELECTED FOR AN ENDOVASCULAR THROMBECTOMY (EVT) PROCEDURE. DURING THE PROCEDURE, THE DEVICE BECAME STUCK ON THE THRUWAY GUIDEWIRE AND KINKED. THE DEVICE HAD TO BE REMOVED TOGETHER WITH THE CATHETER. 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 22330796 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INSUFFICIENT FLOW OCCURRED, AND ADDITIONAL TREATMENT WAS REQUIRED TO RESTORE BLOW FLOW INSIDE THE PATIENT. A 1.85MM JETSTREAM SC AND 2.4MM JETSTREAM XC ATHERECTOMY CATHETERS WERE SELECTED FOR USE. TO PERFORM AN ABLATION ON A MILDLY TORTUOUS, 75% STENOSED AND SEVERELY CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). AFTER PLACING A 6.5MM FILTERWIRE, ABLATION WAS PERFORMED ON THE DISTAL SEGMENT OF THE SFA. TWO PASSES THROUGH THE LESION WERE MADE IN BLADES-DOWN MODE, AND ONE PASS WAS MADE IN BLADES-UP MODE. AFTER BLADES-UP MODE WAS USED WITH THE XC CATHETER, PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED. SUBSEQUENT CONTRAST IMAGING INDICATED SLOW FLOW, AND THE DISAPPEARANCE OF FLOW IN THE ANTERIOR TIBIAL ARTERY (ATA). ADDITIONAL TREATMENT WAS PERFORMED TO RESTORE BLOOD FLOW IN THE ARTERY, THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Reduced Blood Flow

  MAUDE report 21574140 ↗

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