OUTBACK OTB59080ARecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 20705032067567), received between May 26, 2017 and Nov 9, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2025Difficult to Remove; Difficult to Remove

  AS REPORTED, THE 80 CM OUTBACK RE-ENTRY CATHETER EXPERIENCED A FAILURE WHEN THE WIRE PROTRUDED PERPENDICULARLY THROUGH THE NEEDLE RATHER THAN EXITING THE DISTAL TIP. MULTIPLE WIRES WERE USED DURING THE PROCEDURE, AND THE STAFF BELIEVES THE NON-CORDIS GUIDEWIRE WAS WHAT CAUSED THE ISSUE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507099 ↗
• MalfunctionNov 7, 2025Difficult to Remove; Difficult to Remove

  AS REPORTED, NEEDLE DEPLOYMENT OF A 5.9F 80CM OUTBACK ELITE RE-ENTRY CATHETER BECAME DIFFICULT DURING A RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) CHRONIC TOTAL OCCLUSION (CTO) PROCEDURE. ACCESS WAS INITIALLY ATTEMPTED FROM THE RIGHT SFA ORIGIN, BUT A STABLE SHEATH COULD NOT BE MAINTAINED FROM THE LEFT SIDE. RETROGRADE DISTAL FEMORAL ACCESS WAS THEN GAINED; HOWEVER, THE SUBINTIMAL LESION COULD NOT BE CROSSED WITH A CORDIS STABILIZER 0.014 STEERABLE GUIDEWIRE. THE OUTBACK DEVICE WAS FLUSHED AND PREPARED PER THE INSTRUCTIONS FOR USE, WITH NO ABNORMALITIES OBSERVED AT THAT TIME. THE SUBINTIMAL TRACT WAS PRE-DILATED WITH A 3MM BALLOON PRIOR TO DEVICE PASSAGE, AND THE OUTBACK CATHETER WAS ADVANCED ALONG THE SAME GUIDEWIRE TO THE PROXIMAL SFA. DURING USE, NEEDLE DEPLOYMENT BECAME DIFFICULT. THE DEVICE WAS REMOVED AND INSPECTED, REVEALING THAT THE CANNULAR NEEDLE WAS ADVANCING OUT OF THE DISTAL END OF THE CATHETER RATHER THAN THE SIDE AS INTENDED. THE DEVICE WAS DISCARDED, AND A NEW OUTBACK DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. NO DAMAGES WERE FOUND ON THE DEVICE OR ITS PACKAGING PRIOR TO OPENING, AND THE DEVICE HAD BEEN STORED ACCORDING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23499748 ↗
• MalfunctionMay 19, 2025Fracture; Fracture

  AS REPORTED, DURING PREPARATION OF AN 80CM OUTBACK ELITE RE-ENTRY CATHETER, WHEN MOISTENING THE CATHETER WITH A WET COMPRESS, THE TIP OF THE CATHETER LOOSENS AND PULLS OFF. THE DEVICE WAS NOT USED IN THE PATIENT AND A NEW OUTBACK RE-ENTRY CATHETER DEVICE WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THERE WERE NO DAMAGES OR ANOMALIES NOTED TO THE DEVICE OR PACKAGING PRIOR TO OPENING, AND NO ISSUES WERE EXPERIENCED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS PROPERLY STORED AND OPENED IN THE STERILE FIELD. HEPARINIZED SALINE WAS USED FOR PREPARATION AND FLUSHING OF ALL PORTS. THE CATHETER WAS NOT BENT OR COILED AT ANY POINT DURING PREPARATION. THE USER WAS TRAINED TO THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043439 ↗
• MalfunctionAug 15, 2024Fracture; Fracture

  AS REPORTED, THE NEEDLE OF THE 80CM OUTBACK ELITE RE-ENTRY CATHETER COULD NOT BE DEPLOYED BY THE PHYSICIAN. ALTHOUGH THEY TESTED THAT THE NEEDLE COULD EXTEND AND RETRACT BEFORE INSERTING IT INTO THE PATIENT, WHICH WORKED VERY WELL, ONCE IT WAS THERE, THE PHYSICIAN WAS NO LONGER ABLE TO ADVANCE THE NEEDLE OUT OF THE SHAFT. TO COMPLETE THE PROCEDURE, THEY USED ANOTHER OUTBACK DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN, WHO HAS BEEN USING THE DEVICE FOR MANY YEARS, WAS TRAINED IN ITS USE. THERE WERE NO DAMAGES FOUND TO THE DEVICE PACKAGING PRIOR TO USE, AND NO ISSUES WERE EXPERIENCED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE CATHETER WAS NOT COILED AT ANY POINT. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PER PE FINDINGS, THE RESULTING IMAGE SHOWS A SEPARATION OF THE CANNULA. THE SEPARATED CONDITION IS LOCATED AT THE EXACT PORTION OF THE KINK LOCATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19989720 ↗
• MalfunctionMar 26, 2024Fracture; Fracture

  AS REPORTED, VERY CALCIFIED VESSEL, THE OUTBACK NEEDLE CAME NOT OUT OF THE DEVICE AFTER SOME ATTEMPTS. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, BOTH WERE NOT OBTAINED AFTER MULTIPLE ATTEMPTS MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18980483 ↗
• MalfunctionFeb 21, 2023Fracture; Fracture

  AS REPORTED, DURING PREPARATION OF THE OUTBACK ELITE RE-ENTRY CATHETER, THE DEVICE WAS FLUSHED, AND FUNCTION WAS CHECKED. AT THAT MOMENT, THE NEEDLE HAS BEEN DEPLOYED AND CAME OUT OF THE SHAFT POINTING INTO THE WRONG DIRECTION AND IT WAS NOT POSSIBLE TO RETRACT IT ANYMORE. THE LEVER ON THE HANDLE IS MOVEABLE BUT HAS NO MORE FUNCTION. THE NEEDLE WAS STUCK. THE DEVICE WAS NOT INSERTED INTO THE VESSEL/PATIENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION. THE PRODUCT EVALUATION REVEALED THAT THE CANNULA/NEEDLE OF THE OUTBACK ELITE RE-ENTRY CATHETER IS FRACTURED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409901 ↗
• MalfunctionJul 7, 2022Fracture; Fracture

  AS REPORTED, TWO 80CM RE-ENTRY OUTBACK ELITE CATHETER ¿GOT STUCK¿ IN THE NON-CORDIS INTRODUCERS. THE FIRST DEVICE WAS USED WITH THE 7F NON-CORDIS SHEATH, AND THE SECOND DEVICE WAS USED WITH THE 8F NON-CORDIS SHEATH. THERE WAS RESISTANCE FELT IN THE INTRODUCER AND WHEN THE HEALTH CARE PROFESSIONAL WITHDREW THE DEVICE, THE OUTBACK ELITE TIP WAS HUNG BY A SMALL METAL WIRE. THE TIP WAS NOTED TO BE STILL CONNECTED AND NOT IN SEPARATE PIECES. THE CASE WAS COMPLETED WITH THE USE OF ANOTHER CTO TECHNIQUE. THE LESION WAS TREATED SUCCESSFULLY. THERE WERE NO REPORTS OF PATIENT INJURY. THE HEALTHCARE PROFESSIONAL WAS TRAINED IN THE USE OF THIS DEVICE. THE BIFURCATION WAS NOT STEEP OR SHARP. THE DEVICES WERE PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO APPARENT DAMAGE TO EITHER DEVICE PRIOR TO USE. ALL SPECIFIED PORTS WERE FLUSHED WITH HEPARINIZED SALINE. THE PORTS WERE FLUSHED, FOLLOWED BY A 30 SECOND PAUSE, AND THEN FLUSHED AGAIN. THE CANNULA ACTUATION WAS VERIFIED OUTSIDE THE PATIENT. THE CATHETERS WERE HELD IN A STRAIGHT ORIENTATION, WITH ¿NO SLACK¿ DURING PREPARATION. THE NEEDLES DID OPERATE SMOOTHLY DURING PREP. THE CATHETER WAS NOT COILED AT ANY TIME PRIOR TO INSERTION. A .01

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14951578 ↗
• MalfunctionDec 2, 2021Partial Blockage; Partial Blockage

  AS REPORTED, THE NEEDLE OF THE OUTBACK ELITE 80CM RE-ENTRY CATHETER WOULD NOT COME OUT INSIDE THE PATIENT. THE DOCTOR REMOVED THE OUTBACK FROM THE PATIENT. THE DOCTOR TOOK A NEW OUTBACK DEVICE AND THE PROCEDURE SUCCEEDED. THE DEVICE WAS RETURNED FOR ANALYSIS AND AS A RESULT OF THE INSPECTION, THE TIP OF A NON-CORDIS WIRE WAS OBSERVED STUCK INSIDE THE CANNULA. THE UNIT WAS CROSS-SECT SECTIONED CONFIRMING THE PRESENCE OF A NON-CORDIS WIRE SEGMENT WAS STUCK INSIDE OF THE CANNULA. THE HOSPITAL HAS INDICATED THAT THEY DID RETRACT THE WIRE FOR AT LEAST 5CM. IT IS UNKNOWN WHY THE WIRE TIP HAS SEPARATED IN THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). DURING TESTING THE OUTBACK WORKED FINE. ONCE REMOVED FROM THE PATIENT THE NEEDLE DID NOT MOVE AS WELL. THERE WAS NO DAMAGE TO THE OUTBACK DEVICE NOTICED PRIOR TO OPENING THE PACKAGE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. ALL THE SPECIFIED PORTS OF THE DEVICE WERE PROPERLY FLUSHED. THE PORTS WERE FLUSHED, FOLLOWED BY A 30 SECOND DELAY, AND THEN FLUSHED AGAIN. A 0.014¿¿ NON-CORDIS GUIDEWIRE WAS USED. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916021 ↗
• MalfunctionOct 22, 2021Stretched; Unraveled Material; Stretched; Unraveled Material

  DURING A SUBINTIMAL RECANALIZATION, A .014¿ 180CM STABILIZER STEERABLE GUIDEWIRE (SGW) WAS EXCHANGED FROM ANOTHER WIRE TO FACILITATE THE USE OF AN 80CM OUTBACK ELITE RE-ENTRY CATHETER. THE OUTBACK CATHETER WAS INSERTED OVER THE STABILIZER GUIDEWIRE UNTIL IT REACHED THE DESIRED POSITION FOR RE-ENTRY. AFTER THAT, AN ATTEMPT TO RETRACT THE STABILIZER GUIDEWIRE FROM THE OUTBACK GUIDEWIRE LUMEN TO EXIT THE NEEDLE FOR THE RE-ENTRY IN THE TRUE LUMEN FAILED. THE TIP OF THE STABILIZER GUIDEWIRE WAS APPROXIMATELY 9MM OUTSIDE THE DISTAL TIP OF THE OUTBACK CATHETER AND DID NOT MOVE FURTHER INSIDE. HENCE, THE STABILIZER GUIDEWIRE AND THE OUTBACK WERE PULLED OUTSIDE THE VESSEL ALTOGETHER. OUTSIDE THE PATIENT AND DURING AN INSPECTION OF THE DEVICE, ANOTHER ATTEMPT WAS MADE TO RETRACT THE DISTAL TIP OF THE STABILIZER GUIDEWIRE AND IT SEPARATED. A NEW .014 STABILIZER GUIDEWIRE AND OUTBACK RE-ENTRY CATHETER WERE USED TO FINISH THE PROCEDURE SUCCESSFULLY. ANALYSIS OF THE OUTBACK CATHETER INDICATES ELONGATION WAS NOTED AT THE END OF THE STRAIN RELIEF. THERE WAS NO REPORTED PATIENT INJURY. INITIALLY, AFTER SUBINTIMAL CROSSING OF A LONG OCCLUSION USING A GUIDEWIRE AND CATHETER, A PTA BALLOON WAS USED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12681279 ↗
• MalfunctionOct 20, 2020Fracture; Difficult to Remove; Fracture; Difficult to Remove

  AS REPORTED, WHEN THE 80CM OUTBACK ELITE WAS ATTEMPTED TO BE REMOVED, THERE WAS SOME RESISTANCE ¿DUE TO TOP OF CROTCH¿. SOME LIMITED TRACTION WAS GIVEN TO THE SYSTEM, AND THE TIP OF THE OUTBACK BROKE. THE BROKEN PART WAS STUCK HALFWAY THROUGH THE LONG SHEATH. THE LONG SHEATH WAS REMOVED IN ITS ENTIRETY TERMINATING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. ORIGINALLY, THE PATIENT PRESENTED WITH LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WHICH REQUIRED RE-CANALIZATION VIA THE RIGHT, POSSIBLY THE LEFT ILIAC WHICH HAD SIGNS OF STENOSIS. THE AORTIC BIFURCATION WAS NOTED TO BE SOMEWHAT STEEP BUT STRETCHED REASONABLY AFTER THE PLACEMENT OF AN UNKNOWN STIFF WIRE AND A 55CM 6F FLEXOR SHEATH. THE USER WAS TRAINED WITH THE DEVICE. THE DEVICE WAS OPENED IN A STERILE FIELD. THE OUTBACK WAS USED AS THERE WAS DIFFICULTY WITH THE RE-CANALIZATION AND THE USER COULD NOT GET RE-ENTRY. THE OUTBACK WENT OVER THE BIFURCATION, WHICH WAS NOT TOO STEEP, TO THE DISTAL END OF THE SFA UNDER ANGIO FOR POSITIONING. AS THERE APPEARED TO BE A ¿SPONTANEOUS FENESTRATION¿, A MICROWIRE WAS ATTEMPTED TO BE USED WITHOUT HITTING THE LUMEN OF THE OUTBACK. THIS DID NOT WORK WELL WITH THE OUTBACK IN SITU AND THEREFOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10704961 ↗
• MalfunctionSep 21, 2020Fracture; Fracture

  AS REPORTED, THE 80CM OUTBACK ELITE RE-ENTRY FAILED TO CROSS ON THE FIRST ATTEMPT. DURING PROCEDURE, WHEN THE OUTBACK WAS REMOVED FROM THE PATIENT FOR A SECOND ATTEMPT TO CROSS THE LESION, THE TIP OF THE OUTBACK BROKE OFF OUTSIDE THE PATIENT WHEN IT WAS THREADED ONTO THE UNKNOWN GUIDEWIRE. THE PROCEDURE WAS FINISHED WITH ANOTHER OUTBACK DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE PATIENT¿S CONDITION WAS SATISFACTORY. THE DEVICE WAS STORED PER LABELING AND OPENED IN THE STERILE FIELD. THE DEVICE WAS PREPPED AS SPECIFIED BY THE INSTRUCTIONS FOR USE. THERE WERE NO APPARENT DAMAGES TO THE DEVICE NOTICED PRIOR TO USE. ALL SPECIFIED PORTS ON THE DEVICE WERE FLUSHED, FOLLOWED BY A 30 SECOND PAUSE, AND THEN FLUSHED AGAIN. THE CATHETER WAS HELD IN A STRAIGHT ORIENTATION, WITH ¿NO SLACK¿ DURING PREPARATION. THE PATIENT¿S ANATOMY WAS NOT TORTUOUS. THE USERS WANTED TO CROSS A VERY CALCIFIED LESION; THE LESION WAS SEVERELY CALCIFIED. THE DEGREE OF STENOSIS WAS 100%. THERE WAS TOTAL OCCLUSION. THE USER ENCOUNTERED SIGNIFICANT RESISTANCE DURING THE PROCEDURE. THERE WAS NO ABNORMAL FORCE REQUIRED AT ANYTIME DURING THE PROCEDURE. THE EVENT CAUSED AN UNSPECIFIED INCREASE IN THE DURATIO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10560269 ↗
• InjuryOct 8, 2019Retraction Problem; Retraction Problem

  AS REPORTED, THERE WAS RESISTANCE WHEN ATTEMPTING TO WITHDRAW THE NEEDLE OF AN OUTBACK DEVICE. THE NEEDLE WAS ABLE TO BE PULLED BACK WITH A LOT OF EFFORT. ONCE THE NEEDLE CAME BACK IN, THE GUIDE COULD NOT GO THROUGH THE DEVICE AND WAS LET OUT IN THE REAL ARTERIAL VESSEL LUMEN. THE DEVICE WAS PULLED OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE OCCLUDED SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL LEVEL OF CALCIFICATION IS SEVERE. THE VESSEL LEVEL OF ANGULATION IS NONE. THE VESSEL LEVEL OF TORTUOSITY IS MILD. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE DURING WITHDRAWAL FROM PACKAGE. THE DEVICE WAS NOT RESTERILIZED. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREP NORMALLY. THERE WERE NO ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED. THE CATHETER WAS FLUSHED WITH HEPARINIZED SALINE. INITIALLY, THERE WAS NO EXCESS FORCE USED DURING INSERTION. THE CATHETER WAS NOT TORQUED AGAINS

  Patient problems: No Code Available

  MAUDE report 9166990 ↗
• MalfunctionMay 26, 2017Retraction Problem; Retraction Problem

  BEFORE USED ON THE PATIENT, IT WAS REPORTED THAT THE OUTBACK ELITE 80CM RE-ENTRY WAS FAULTY. ADDITIONAL INFORMATION WAS RECEIVED AND THE NEEDLE DEPLOYED BUT WOULD NOT RETRACT BACK. THERE WAS NO PATIENT INJURY. THE PRODUCT WAS FLUSHED CORRECTLY. ONCE FLUSHED, THE NEEDLE WOULD NOT RETRACT AGAIN SO THE DEVICE WAS NOT USED IN THE PATIENT. THIS IS THE FIRST TIME THIS HAS HAPPENED IN THIS CENTRE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6594050 ↗