CaravelRecalls & reported problems across all models

We found 2 models of Caravel by Asahi Intecc CO., Ltd. in the FDA's device registry (GUDID). Together they are named in 58 adverse event reports in the FDA's MAUDE database, received between May 14, 2017 and Jun 9, 2026 — classified as 37 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (30 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 Caravel problems

Caravel models

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

• Caravel CRV135-19P

  CATHETER, PERCUTANEOUS
  42 reports
• Caravel CRV150-19P

  CATHETER, PERCUTANEOUS
  16 reports

Recent Caravel adverse event reports

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

• MalfunctionJun 9, 2026Material Fragmentation

  THE TIP OF THE MICROCATHETER CAME OFF DURING PROCEDURE. THEY TRIED TO RETRIEVE IT AND WERE UNSUCCESSFUL. THE CARAVEL WAS USED IN THE DISTAL LAD AND THE TIP CAME OFF IN THE PATIENTS BODY AND WAS NOT ABLE TO BE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25443504 ↗
• MalfunctionMar 2, 2026Break; Material Fragmentation

  WHILE CROSSING THE CIRC TO THE OM [OBTUSE MARGINAL] LESION. WHEN DR PULLED THE CARAVEL MICRO CATHETER BACK, HE SAW THAT THE TIP WAS NOT MOVING ON XRAY FLUORO AND HAD BROKEN OFF THE CARAVEL MICROCATHETER. HE RECAPTURED THE BROKEN TIP IN THE GUIDE CATHETER AND REMOVED EVERYTHING ON THE WIRE. WHILE LOOKING AT THE BROKEN TIP WHICH WAS AROUND 1MM IN SIZE THE DR DROPPED IT ON THE SCRUB TABLE AND IT ROLLED OFF. [REDACTED] WITNESSED DR DROP THE PIECE, BUT THEY COULD NOT LOCATE IT AFTERWARDS. DR THEN REWIRED LESION AND USED DIFFERENT BRAND OF MICROCATHETER TO PROCEED WITH CASE.

  Patient problems: Insufficient Information

  MAUDE report 24489766 ↗
• InjuryFeb 16, 2026Material Separation

  IT WAS REPORTED THAT AN ASAHI CARAVEL MICROCATHETER WAS USED FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE TIP OF THE CARAVEL MICROCATHETER WAS TORN OFF. AN ATTEMPT WAS MADE TO RETRIEVE THE CATHETER TIP FRAGMENT USING A SNARE. AS A RESULT, THE CATHETER TIP FRAGMENT COULD NOT BE RETRIEVED. THE PHYSICIAN DECIDED TO LEAVE THE TIP FRAGMENT IN SITU. BLOOD FLOW COULD NOT BE REESTABLISHED. IT WAS INFORMED THAT THERE WAS NO ADVERSE PATIENT EFFECT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24341906 ↗
• InjuryFeb 9, 2026Material Separation

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A MILDLY CALCIFIED, MILDLY FLEXUOUS, AND MODERATELY TORTUOUS CHRONIC TOTAL OCCLUSION (CTO) IN THE RIGHT CORONARY ARTERY (RCA). AN ASAHI CARAVEL MICROCATHETER WAS USED TO ANTEGRADELY CROSS THE RCA AND THEN RETROGRADELY ADVANCED THROUGH AN EPICARDIAL COLLATERAL CHANNEL TO CROSS SEPTAL CHANNELS AND THE GRAFT. HOWEVER, CROSSING THE CTO WAS UNSUCCESSFUL. WHEN THE CARAVEL MICROCATHETER WAS BEING REMOVED EX SITU, THE DISTAL TIP OF THE CATHETER WAS FOUND IN THE PATIENT ANATOMY. THEN INTENDED TREATMENT WAS DISCONTINUED, AND A REPEAT ATTEMPT TO CROSS THE CTO LESION WAS PLANNED. THE PHYSICIAN CONCLUDED THAT THE CATHETER FRAGMENT WOULD CAUSE NO ISSUE AND COULD BE LEFT IN SITU. THE DESCRIPTION IN THE INITIAL REPORT INCORRECTLY STATED: THEN INTENDED TREATMENT WAS COMPLETED WITHOUT DELAY OR ISSUE. THE PHYSICIAN CONCLUDED THAT THE CATHETER FRAGMENT WOULD CAUSE NO ISSUE AND COULD BE LEFT IN SITU. IT WAS INFORMED THAT THERE WERE NO HEALTH HAZARDS CAUSED TO THE PATIENT DUE TO THE REPORTED EVENT. THEREFORE, THE POST-EVENT DESCRIPTION WAS CHANGED TO: THEN INTENDED TREATMENT WAS DISCONTINUED, AND A REPEAT ATTEMPT TO CROSS

  Patient problems: Foreign Body In Patient

  MAUDE report 24288754 ↗
• MalfunctionFeb 6, 2026Material Fragmentation

  DR. (B)(6) HAD THE TIP OF A CARAVEL COME OFF IN A PATIENT. DR. (B)(6) REMOVED THE TIP WITH A SNARE.

  Patient problems: Insufficient Information

  MAUDE report 24279071 ↗
• MalfunctionFeb 4, 2026Material Fragmentation

  WHILE ATTEMPTING TO GO RETROGRADE THROUGH AN EPICARDIAL, THE OPERATOR NOTICED A PIECE OF THE DISTAL TIP OF THE CARAVEL MICROCATHETER HAD SHEARED OFF. THE PIECE OF THE MICROCATHETER WAS NOTICED WHILE REMOVING THE CARAVEL FROM THE ANATOMY. THE OPERATOR ATTEMPTED GOING RETROGRADE THROUGH THIS EPICARDIAL AFTER ATTEMPTING TO GO ANTEGRADE THROUGH THE NATIVE RCA AND TRYING TO GO RETROGRADE THROUGH THE SEPTALS AS WELL AS THE GRAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260132 ↗
• MalfunctionDec 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A 90-99% STENOSIS IN THE OBTUSE MARGINAL BRANCH (OM). AN ASAHI CARAVEL MICROCATHETER AND A TERUMO RUNTHROUGH NS GUIDE WIRE WERE USED TO CROSS THE LESION. AFTER CROSSING THE LESION, THE COIL OF THE RUNTHROUGH NS GUIDE WIRE WAS FOUND LOOSENED AND FOREIGN OBJECT WAS OBSERVED ON THE GUIDE WIRE BY ANGIOGRAPHY. WHEN ALL DEVICES WERE WITHDRAWN, THE TIP OF THE CARAVEL MICROCATHETER WAS TORN OFF. IT WAS CONFIRMED THAT NO FRAGMENTS REMAINED IN THE PATIENT ANATOMY. THE DEVICES WERE THEN REPLACED WITH AN UNSPECIFIED GUIDING CATHETER, A CARAVAL MICROCATHETER, AN ASAHI SION BLUE GUIDE WIRE, AN UNSPECIFIED GUIDE EXTENSION CATHETER, AND AN UNSPECIFIED STENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT AND THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23724227 ↗
• MalfunctionNov 20, 2025Material Fragmentation; Unraveled Material; Material Fragmentation; Unraveled Material

  THE PATIENT WAS SET UP FOR A PCI OF THE OBTUSE MARGINAL. FEMORAL ACCESS WAS ACHIEVED AND A 6F 3.5 EBU GUIDE WAS UTILIZED. THE PHYSICIAN USED A CARAVEL AND TERUMO RUNTHROUGH WIRE. AFTER NOTICING THE GUIDE WIRE UNCOILED AFTER CROSSING, HE ALSO NOTICED SOMETHING ON THE WIRE UNDER FLUOROSCOPY. HE THEN REMOVED EVERYTHING AND NOTICED THE CARAVEL TIP CAME OFF. AFTER HE CONFIRMED NOTHING WAS LEFT IN THE PATIENT, HE PROCEEDED WITH PROCEDURE WITH SAME GUIDE CATHETER AND NOW CHANGED OUT FOR SION BLUE, CARAVEL, GUIDE EXTENSION, AND STENT. HE COMPLETED THE PROCEDURE IN THE NORMAL FASHION WITH NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610491 ↗
• MalfunctionFeb 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT A HEAVILY CALCIFIED 99% STENOSIS IN THE RIGHT CORONARY ARTERY (RCA) FOR A PATIENT WITH NON-ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI). AN ASAHI CARAVEL MICROCATHETER WAS ADVANCED OVER A NON-ASAHI GUIDE WIRE AND WAS DELIVERED TO THE HEAVILY TORTUOUS, CALCIFIED LESION. THE GUIDE WIRE WAS EXCHANGED FOR A NON-ASAHI ROTA WIRE AND THEN A RUN THROUGH GUIDE WIRE. WHEN A NON-ASAHI TRAPPER EXCHANGE DEVICE WAS USED TO REMOVE THE CARAVEL MICROCATHETER, THE CARAVEL MICROCATHETER WAS FELT LIKE STUCK, AND THE CATHETER TIP WAS FOUND TORN OFF AND REMAINED ON THE GUIDE WIRE. THE SEPARATED CATHETER TIP WAS REMOVED TOGETHER WITH THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUE. IT WAS INFORMED THAT PATIENT'S HEALTH CONDITION WAS NORMAL AFTER THE PROCEDURE, BUT THE PATIENT PASSED AWAY DUE TO COMORBID ISSUE UNRELATED TO THIS INCIDENT AFTER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372282 ↗
• MalfunctionJan 31, 2025Crack; Material Fragmentation; Crack; Material Fragmentation

  CARAVEL WAS ADVANCED IN A NORMAL FASHION OVER A RUNTHROUGH GUIDEWIRE IN AN N-STEMI CASE ON A 74-YEAR-OLD FEMALE'S RCA. THE VESSEL HAD A 99% CALCIFIED, TORTUOUS LESION. CARAVEL WAS USED TO EXCHANGE TO ROTO WIRE, AND AFTER ROTO, IT WAS EXCHANGED BACK TO RUNTHROUGH WIRE. WHILE REMOVING CARAVEL WITH TRAPPER, CARAVEL SEEMED TO BE STUCK. AS THEY WENT TO A BALLOON LESION, THEY NOTICED THAT 1MM OF THE DISTAL TIP HAD CRACKED ON THE WIRE IN THE RCA. MD REMOVED THE WIRE WITH THE ENTIRE GUIDEWIRE SYSTEM. THE 1MM OF CARAVEL CAME OUT. THERE WAS NO PATIENT INJURY. MD COMPLETED THE CASE IN THE NORMAL FASHION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289020 ↗
• MalfunctionDec 10, 2024Material Fragmentation; Material Fragmentation

  THE TIP OF A CARAVEL MICROCATHETER FRAGMENTED INTO THE CIRCUMFLEX CORONARY ARTERY VESSEL. ALL FRAGMENTS WERE RETRIEVED SUCCESSFULLY. THE CARDIAC CATHETERIZATION WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT OR SUBSEQUENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20898234 ↗
• MalfunctionNov 2, 2023Material Fragmentation; Material Fragmentation

  PHYSICIAN STARTED OUT WITH A CORSAIR, AND MOVED TO CARAVEL AND TIP DISLODGED AND LEFT IN PATIENT. NO ADVERSE EVENTS, PATIENT IS DOING FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18061587 ↗
• InjuryOct 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ASAHI CARAVEL MICROCATHETER WAS USED TO CROSS A MODERATELY CALCIFIED LESION AT THE MID LEFT CIRCUMFLEX CORONARY ARTERY (LCX) DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI). WHEN THE CARAVEL MICROCATHETER GOT CAUGHT IN THE LESION AND WITHDRAWAL MANIPULATION WAS APPLIED, THE CATHETER TIP WAS DETACHED AND LEFT IN THE PATIENT ANATOMY. ALTHOUGH AN ATTEMPT WITH SNARE WAS MADE TO RETRIEVE, THE TIP FRAGMENT WAS EMBEDDED IN THE CALCIUM AND COULD NOT BE REMOVED. THE PHYSICIAN DECIDED TO TREAT THE PATIENT CONSERVATIVELY AND STOPPED THE PROCEDURE. IT WAS INFORMED THAT THERE WAS NO IMPACT ON THE PATIENT, WHO WAS DISCHARGED AFTER THE PROCEDURE AND WAS DOING FINE WITH NO HEALTH HAZARD.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18036953 ↗
• InjuryDec 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI CARAVEL MICROCATHETER SEPARATED DURING A RETROGRADE PCI APPROACHING THROUGH RCA EPICARDIAL TO LAD. AN ASAHI CORSAIR PRO XS MICROCATHETER WAS ADVANCED WITH NO ISSUES OVER AN ASAHI SION BLACK GUIDE WIRE. XS WOULDN'T PASS CORKSCREW SPIRAL IN EPICARDIAL COLLATERAL. SION BLACK WAS CHANGED OUT FOR SUOH 03 GUIDE WIRE. WIRE WAS ABLE TO TRAVEL INTO LAD AND TO DISTAL CAP OF THE PROX LAD CTO. XS WAS UNABLE TO CONTINUE ALONG SUOH 03. XS WAS EXCHANGED FOR CARAVEL. CARAVEL WAS UNABLE TO NAVIGATE THROUGH THE CORKSCREW SPIRAL. CARVEL WAS REMOVED AND IT APPEARED TO FRACTURE IN EPICARDIAL. ON FLUOROSCOPY, IT APPEARED AS A RADIOPAQUE WELD POINT ON THE SUOH 03. MAKING ASSUMPTIONS THAT THE SUOH 03 MAY HAVE KINKED OR SPLINTERED. FINECROSS M3 WAS THEN ADVANCED OVER SUOH 03. M3 WOULDN'T PASS CORKSCREW AS WELL, M3 AND SUOH 03 WERE REMOVED. THERE WAS A SLICE OF SOMETHING LEFT IN THE EPICARDIAL. A NEW SUOH 03 WAS INSERTED OVER THE M3 AND BOTH WIRE AND MICROCATHETER WERE ADVANCED TO DISTAL SEGMENT OF THE CTO, USING SAME EPICARDIAL. RETAINED ITEM WASN'T RETRIEVED FROM EPICARDIAL. NO ADVERSE OUTCOMES OCCURRED. PATIENT REMAINED STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16048857 ↗
• InjuryDec 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  SUS VOLUNTARY EVENT REPORT NUMBER: MW5096830 WAS RECEIVED FROM THE US DISTRIBUTOR. IT WAS REPORTED AS FOLLOWS: RETAINED MICROCATHETER "9/" MD USING AN ASAHI CARAVEL MICROCATHETER DURING PCI OF A CHRONIC TOTAL OCCLUSION. AS HE PULLED BACK, THE TIP OF THE CATHETER DISLODGED MID RCA AND WAS UNABLE TO BE RETRIEVED. IT WAS FELT THAT THE RIGHT LESION WAS THE CAUSE, NOT A FAULTY PRODUCT. COMPLICATION WAS DISCUSSED WITH PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11043307 ↗

Other Asahi Intecc CO., Ltd. products

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