EXPORT® AP EXPORTAPRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00613994431745), received between Oct 27, 2017 and Feb 11, 2026 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (8 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Suction Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE 6F EXPORT ASPIRATION CATHETER, WHEN THE DEVICE FAILED TO ASPIRATE COMPLETELY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE CATHETER COULD NOT BE ASPIRATED AS SOON AS THE ASPIRATION WAS ABOUT TO BEGIN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314164 ↗
• MalfunctionNov 12, 2025Peeled/Delaminated; Material Deformation; Material Split, Cut or Torn; Peeled/Delaminated; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE 6F EXPORT ASPIRATION CATHETER WAS DEFORMED IN VIVO. IT WAS NOTED THAT THE DEVICE WAS FRAYED UPON REMOVAL FROM THE PATIENT. THE DEVICE WAS INSPECTED PRIOR TO USE AND PREPPED PER IFU WITH NO ISSUES NOTED. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. NO EXCESSIVE FORCE WAS USED DURING INSERTION OR DELIVERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23538566 ↗
• MalfunctionNov 12, 2025Suction Problem; Device Damaged by Another Device; Material Deformation; Suction Problem; Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE 6F EXPORT ASPIRATION CATHETER, IT WAS DISCOVERED THAT THE GUIDEWIRE LUMEN OF THE ASPIRATION CATHETER WAS DAMAGED. THE GUIDEWIRE LUMEN WAS NOTED TO BE DAMAGED WHEN SUCTION WAS UNSUCCESSFUL WHILE INSIDE THE PATIENT'S BODY. THE DEVICE WAS REMOVED AND THE DAMAGE WAS NOTED TO THE GUIDEWIRE LUMEN. WIRE MANAGEMENT ISSUES OCCURRED WHEN THE NON-MEDTRONIC WIRE LOOPED DURING USE BUT DID NOT OCCUR INSIDE THE PATIENT'S BODY. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WHICH EXHIBITED MILD TORTUOSITY, NO CALCIFICATION AND 95% STENOSIS. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED PRIOR TO USE AND PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS NOT NOTED DURING INSERTION OF THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING USE. THE GUIDEWIRE WAS PREPPED AS PER IFU. THE SAME MODEL OF PRODUCT WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23531528 ↗
• MalfunctionNov 3, 2023Entrapment of Device; Difficult to Insert; Difficult to Remove; Material Deformation; Positioning Problem; Material Split, Cut or Torn; Entrapment of Device; Difficult to Insert; Difficult to Remove; Material Deformation; Positioning Problem; Material Split, Cut or Torn

  AN ATTEMPT WAS MADE TO USE ONE EXPORT AP ASPIRATION CATHETER DURING A PROCEDURE ON THE SAPHENOUS VEIN GRAFT (SVG) TO THE DIAGONAL BRANCH. THE PROXIMAL AND MID SVG HAD A PREVIOUSLY DEPLOYED NON-MEDTRONIC STENT WITH 90% IN-STENT RESTENOSIS (ISR), A SMALL ROUND THROMBUS, AND HAZY OPACITY DISTAL TO THE STENT. THE EXPORT ASPIRATION CATHETER WAS BEING USED TO TREAT THE THROMBUS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. THE INITIAL ATTEMPTS TO CROSS THE LESION WERE UNSUCCESSFUL. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. IT WAS REPORTED THAT THE WIRE LUMEN OF THE ASPIRATION CATHETER WAS DAMAGED. THE EXPORT WAS OVER THE WIRE AND THERE WAS NOTICEABLE RESISTANCE AND FRICTION FROM THE 0.014 NON-MEDTRONIC WIRE. THERE WERE THEN DIFFICULTIES ENCOUNTERED WHEN REMOVING THE EXPORT ASPIRATION CATHETER BACK THROUGH THE 6F LAUNCHER GUIDE CATHETER. THE EXPORT CATHETER, THE WIRE AND THE LAUNCHER GUIDE CATHETER WERE REMOVED AS ONE UNIT. THERE WERE NO DIFFICULTIES EXPERIENCED REMOVING THE EXPORT ASPIRATION CATHETER FROM THE PATIENT'S VASCULATURE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18064088 ↗
• MalfunctionDec 5, 2022Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE 6F EXPORT AP CATHETERS TO TREAT A LESION. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. THE DEVICE WAS PREPARED PER THE IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE EXPORT CATHETER WAS INSERTED AND TRACKED ALONG A GUIDEWIRE INTO A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 90% STENOSIS IN THE MID POSTERIOR INTERVENTRICULAR ARTERY (PDA). RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DISTAL RIGHT CORONARY ARTERY (RCA) AND POSTERIOR INTERVENTRICULAR ARTERY (PDA) BIFURCATION WAS STENTED AS A RESULT, OF IN STENT RESTENOSIS (IRS) FROM A BARE METAL STENT (BMS) WHICH HAD BEEN IMPLANTED 9 YEARS PREVIOUSLY. IT WAS NOTICED THAT PLAQUE HAD SHIFTED THEREFORE THE EXPORT DEVICE WAS BEING USED TO ASPIRE THE THROMBUS IN THE POSTERIOR INTERVENTRICULAR ARTERY (PDA). AFTER ADVANCING THE DEVICE DISTALLY AN ATTEMPT WAS MADE TO SLOWLY PULL BACK THE EXPORT DEVICE. RESISTANCE WAS ENCOUNTERED AND BOTH THE 0.014¿ WIRES AND THE EXPORT CATHETER WERE REMOV ED. IT WAS STATED THAT ONE OF THE WIRES MAY HAVE WRAPPED ON THE EXPORT DEVICE. THERE WAS SIGNIFICANT DAMAGE TO AT LEAST ONE OF THE 0.014¿ WIRES A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15913175 ↗
• MalfunctionOct 14, 2022Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE EXPORT AP ASPIRATION CATHETER TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 100% STENOSIS IN THE MID LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE AND THERE WAS NO EXCESSIVE FORCE USED DURING THE INSERTION/DELIVERY OF THE DEVICE. IT WAS REPORTED THAT THERE WAS A METAL PIECE PERTURBING FROM THE DISTAL END OF THE CATHETER. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15605265 ↗
• MalfunctionJul 6, 2022Suction Problem; Suction Problem

  AN ATTEMPT WAS MADE TO USE A 6F EXPORT AP ASPIRATION CATHETER. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. IT WAS REPORTED THAT THE ASPIRATION CATHETER FAILED TO ASPIRATE COMPLETELY. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14926475 ↗
• MalfunctionJul 6, 2021Suction Problem; Suction Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A 6F EXPORT AP ASPIRATION CATHETER. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE REMOVED FROM PACKAGING AS PER IFU. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED AS PER IFU. IT WAS REPORTED THAT THE ASPIRATION CATHETER FAILED TO ASPIRATE COMPLETELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12119992 ↗
• MalfunctionOct 1, 2020Suction Problem; Suction Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE 6F EXPORTAP EXPORT CATHETER TO TREAT A MILDLY TORTUOUS AND CALCIFIED LESION IN THE MID RIGHT SFA WITH 100% CTO. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. IT WAS REPORTED THAT THE DEVICE FAILED TO ASPIRATE COMPLETELY AFTER 4 ATTEMPTS WERE MADE. THE STYLETTE WAS REMOVED PRIOR TO ATTEMPTING ASPIRATION. RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED. A CLOT WAS NOTICE IN THE RIGHT SFA IN THE INSTENT RESTENOSIS. THE EXPORT CATHETER WAS USED TO REMOVE THE CLOT HOWEVER IT WOULD NOT ASPIRATE. A NON MEDTRONIC EXPORT CATHETER WAS USED TO REMOVE THE CLOT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10611850 ↗
• MalfunctionJun 2, 2020Suction Problem; Suction Problem

  AN EXPORT ASPIRATION CATHETER WAS USED DURING A PROCEDURE TO TREAT A MODERATELY CALCIFIED, SEVERELY TORTUOUS LESION EXHIBITING 100% STENOSIS IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THERE WAS SUCTION LOSS. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10107938 ↗
• InjuryApr 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AN EXPORT AP ASPIRATION CATHETER WAS USED DURING A PROCEDURE TO TREAT A LESION IN THE OSTIUM OF THE RCA AND CX ARTERIES. THERE WAS NO TORTUOSITY AND SEVERE CALCIFICATION. NO DAMAGE WAS NOTED TO PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING AS PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED AND PREPPED WITH NO ISSUES FOUND. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND NO EXCESSIVE FORCE WAS USED DURING INSERTION/DELIVERY. IT IS REPORTED THAT DURING THE PROCEDURE, THE MARKING RING AT THE END OF THE SUCTION HEAD FELL OFF AND DROPPED INTO THE BLOOD VESSELS WHEN ATTEMPTING TO REMOVE THE DEVICE. THE DETACHED PORTION REMAINED IN THE BODY, AND COULD NOT BE RETRIEVED. THE DETACHED MARKING RING WAS LEFT IN THE PULMONARY VEIN IN THE PATIENT'S BODY. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8513399 ↗
• InjuryApr 5, 2019Suction Problem; Suction Problem

  DURING A PCI PROCEDURE ((B)(6) 2018) ONE 3.5X22MM RESOLUTE ONYX OTW DRUG ELUTING STENT (PLI 10) WAS USED TO DIRECT STENT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 98% STENOSIS LOCATED IN THE PROXIMAL LAD. THE LESION IN THE PROXIMAL LAD WAS A SEVERE LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE LESION WAS NOT PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE 3.5X22MM RESOLUTE ONYX WAS INFLATED ONCE TO 15 ATM. A DECISION WAS MADE NOT TO GO HIGHER THAN 15ATM BECAUSE THE STENT WAS BEING OVER-SIZED. PREPROCEDURE STENOSIS WAS 90% WITH TIMI 3 FLOW. POST PROCEDURE STENOSIS WAS 0% WITH TIMI 3 FLOW. IT WAS INDICATED THAT THE MID SECTION OF THE STENT AT THE TAKEOFF OF THE DIAGONAL BRANCH WAS NOT FULLY EXPANDED. THAT AREA WAS POST-DILATED TO EXPAND THE STENT AND THE FLOW TO THE DIAGONAL BRANCH WAS COMPROMISED. THERE WAS A SECOND WIRE PLACED IN THE DIAGONAL BRANCH AND A 2.0 X 15MM SPRINTER OTW BALLOON WAS PLACED THROUGH THE S

  Patient problems: Injury

  MAUDE report 8486321 ↗
• MalfunctionNov 6, 2018Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  AN EXPORT AP ASPIRATION CATHETER WAS INTENDED TO BE USED. THE LESION ASSOCIATED WITH THE EVENT WAS LOCATED IN THE PROXIMAL CX, AND WAS SEVERELY TORTUOUS, WITH 95% STENOSIS. NO DAMAGE NOTED TO PACKAGING. NO ISSUES REMOVING THE DEVICE FROM THE PACKAGING AS PER IFU. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED DURING INSERTION/DELIVERY. IT IS REPORTED THAT AFTER THE DEVICE WAS INSERTED INTO THE PATIENT IT WAS NOTED THAT THE MARKER BAND WAS NOTED TO BE MISSING. THE DEVICE WAS THEN REMOVED AND A NEW DEVICE USED. THE MARKER BAND WAS NOT FOUND. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8041712 ↗
• MalfunctionJun 8, 2018Suction Problem; Suction Problem

  AN EXPORT AP DEVICE WAS INTENDED TO BE USED DURING A PROCEDURE. NO DAMAGE WAS NOTED TO THE EXPORT ASPIRATION CATHETER PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS USED IN THE DISTAL RCA WHICH HAD MODERATE TORTUOSITY, MILD CALCIFICATION AND 100% STENOSIS. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT APPLIED. THE CATHETER COMPLETELY FAILED TO ASPIRATE THE THROMBUS. THE PATIENT IS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7581623 ↗
• MalfunctionMar 29, 2018Aspiration Issue; Aspiration Issue

  THERE WAS NO DAMAGE NOTED TO PACKAGING OF THE EXPORTAP ASPIRATION CATHETER. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU AND INSPECTED WITH NO ISSUES NOTED. THE CATHETER WAS NOT PREPPED PER IFU. IT WAS REPORTED THAT THE DEVICE FAILED TO ASPIRATE COMPLETELY. THE STYLETTE WAS REMOVED PRIOR TO THE ATTEMPTED ASPIRATION. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO FORCE WAS APPLIED DURING DELIVERY. THE INTENDED LESION WAS IN THE MID DIAGONAL BRANCH, HAD MILD TORTUOSITY, SEVERE CALCIFICATION AND 100% STENOSIS. AFTER FOUR UNSUCCESSFUL ATTEMPTS TO ASPIRATE USING THE CATHETER, THE CATHETER WAS REPLACED WITH ANOTHER MEDTRONIC DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7380589 ↗
• MalfunctionOct 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS USING AN EXPORT ASPIRATION CATHETER IN A PATIENT WITH MULTI VESSEL DISEASE. THE EXPORT WAS FIRST USED IN THE RCA WITH NO ISSUES NOTED. THE DEVICE WAS THEN USED IN A TORTUOUS LAD. NO RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN REPORTED THAT THE DEVICE MARKER CAME OFF AS THE CATHETER WAS BEING ADVANCED AND POSITIONED. THE PHYSICIAN ENDED UP PULLING EVERYTHING OUT AS A UNIT WITH THE WIRE AND SHEATH, INCLUDING THE MARKER. NO PART OF THE DEVICE REMAINED IN THE PATIENT. NO PATIENT INJURY IS REPORTED. ON REVIEW OF THE RETURNED PARTS, THE MARKER WAS NOT PRESENT, WHICH WAS HIGHLIGHTED TO THE PHYSICIAN. IT WAS CONFIRMED UNDER FLUOROSCOPY THAT NO PART OF THE DEVICE REMAINED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6983017 ↗