OUTBACK OTB42120Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032035016), received between Jul 10, 2017 and May 10, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE ¿L¿ MARKER OF AN OUTBACK LTD RE-ENTRY CATHETER 120CM, DETACHED. IT DETACHED DURING USE IN THE VESSEL AND IS IN THE VESSEL. THE USER IS TRAINED WITH THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM FROM ADDITIONAL INFO: THE "L" MARKER WAS NOTED BE DISLODGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14349413 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER USING THE DEVICE AND ADVANCING THE NON CORDIS GUIDEWIRE INTO THE VESSEL LUMEN, THE OUTBACK LTD KINKED/BENT WHILE GOING OVER THE BIFURCATION AND WOULD NOT RETRACT WITHOUT PULLING IT OUT TOGETHER WITH THE WIRE AS ONE UNIT. THE WIRE COULD NOT BE REMOVED FROM THE DEVICE UNTIL THE WIRE WAS OUT OF THE BODY. THEREFORE, THE PROCEDURE COULD NOT BE SUCCESSFULLY COMPLETED DUE TO LOSS OF WIRE PLACEMENT AND IT CAUSED A PERFORATION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) THAT WAS IMMEDIATELY TREATED USING MANUAL PRESSURE FROM A BLOOD PRESSURE CUFF SINCE WIRE ACCESS HAD BEEN LOST. THE TARGET VESSEL WAS THE SFA. THE ACCESS SITE WAS FEMORAL. THE DEVICE WAS PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE SFA HAS MODERATE CALCIFICATION, NO TORTUOSITY, 100% STENOSIS WITH A CHRONIC TOTAL OCCLUSION (CTO), NO ACUTE ANGLE, AND NO BIFURCATION. THERE WAS NO DAMAGE TO THE OUTBACK DEVICE NOTICED PRIOR TO OPENING THE PACKAGE AND NO APPARENT DAMAGE TO THE DEVICE NOTICED PRIOR TO USE. THE PORTS WERE FLUSHED, FOLLOWED BY A 30 SECOND PAUSE, AND THEN FLUSHED AGAIN. HEPARINIZED SALINE WAS NOT USED FOR PREPARATION AND FLUSHING OF ALL PORTS. THE CATH

  Patient problems: Perforation

  MAUDE report 10755464 ↗
• MalfunctionOct 19, 2020Fracture; Fracture

  AS REPORTED, THE CANNULA TIP OF A 120CM OUTBACK RE-ENTRY CATHETER COULD NOT BE RETRACTED WHEN CHECKING THE FUNCTIONALITY OF THE DEVICE. WHILE CHECKING THE FUNCTIONALITY OF THE OUTBACK, THE CANNULA TIP COULD NOT BE RETRACTED. THE PHYSICIAN TRIED SEVERAL TIMES, BUT IT FELL OFF AND WAS BROKEN. THERE WAS NO REPORTED PATIENT INJURY. THE CANNULA TIP COVER WAS REMOVED AND THE DEVICE WAS FLUSHED. THE DEVICE WAS OPENED IN STERILE FILED. THE DEVICE WAS STORED IN THE CATH LAB IN A COOL DRY PLACE, FOR APPROXIMATELY 9 MONTHS. THE DEVICE WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTICED TO THE DEVICE PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10698179 ↗
• MalfunctionJul 10, 2017Difficult or Delayed Positioning; Fracture; Difficult or Delayed Positioning; Fracture

  IT WAS REPORTED THAT THE OUTBACK RE-ENTRY CATHETER WAS SEPARATED AND THE NEEDLE DID NOT DEPLOY. THERE WERE NO PATIENT INJURY. THE PHYSICIAN TRIED TO RE-ENTER THE ARTERY BY USING THE OUTBACK. HE PUSHED THE BUTTON ON THE HANDLE TO DEPLOY THE NEEDLE BUT THE NEEDLE DIDN'T DEPLOY. HE NOTICED THAT THE HANDLE AND THE BLACK SLEEVE WAS DETACHED. SO HE GRABBED THE HANDLE AND THE BLACK SLEEVE, THEN THE NEEDLE WAS DEPLOYED. THE PATIENT WAS CURED WELL. HE SAID THAT THE HANDLE AND THE BLACK SLEEVE WAS DETACHED FROM THE FIRST.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6697253 ↗