INFINITI 538453SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032014847), received between Feb 9, 2024 and Nov 11, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2024Material Frayed; Material Puncture/Hole; Material Split, Cut or Torn; Material Frayed; Material Puncture/Hole; Material Split, Cut or Torn

  AS REPORTED, THE 4F 110CM PIG INFINITI GUIDING CATHETER TORE DURING THE ROUTINE EXAMINATION WHEN TRYING TO BRING IT FORWARD. THE WIRE CAME OUT OF THE SIDE OF THE CATHETER (NOT THROUGH SHS OR ORIGINAL LUMEN). THE EXAMINER THEN WITHDREW THE DIAGNOSTIC (DX) CATHETER, AND THE TIP BROKE OFF. THE DISTAL PORTION OF THE CATHETER WAS NOTED TO HAVE SEPARATED, ABOUT 5CMS. THE DEVICE WAS NOTED TO HAVE PUNCTURED AND SEPARATED AT THE SAME LOCATION ON THE CATHETER. IT WAS THEN RETRIEVED FROM THE GROIN WITH THE SNARE. THE PROCEDURE WAS COMPLETED WITH A NEW PIGTAIL CATHETER FROM CORDIS. THE DEVICE WAS REMOVED WITHOUT PATIENT INJURY. THE DEVICE WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO APPARENT DAMAGE NOTED ON THE DEVICE PRIOR TO USE. THERE WAS NO RESISTANCE/ FRICTION WHILE ADVANCING THE DEVICE THROUGH THE VESSEL. UNUSUAL FORCE WAS NOT NEEDED TO ADVANCE OR WITHDRAW THE CATHETER FROM THE PATIENT. THE UNKNOWN LESION WAS NOTED TO HAVE NO CALCIFICATION. THE VESSEL WAS NOT TORTUROUS. A NON-CORDIS .035 150CM WIRE WAS USED WITH THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION. AN ADDITIONAL, STERILE INFINITI PIGTAIL CATHETER WAS RETURNED FOR EVALUATION. THE EVALUATION SHOWS PUNCTU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652718 ↗
• MalfunctionSep 6, 2024Material Puncture/Hole; Detachment of Device or Device Component; Material Puncture/Hole; Detachment of Device or Device Component

  AS REPORTED, THE 4F 110CM PIG INFINITI GUIDING CATHETER TORE DURING THE ROUTINE EXAMINATION WHEN TRYING TO BRING IT FORWARD. THE WIRE CAME OUT OF THE SIDE OF THE CATHETER (NOT THROUGH SHS OR ORIGINAL LUMEN). THE EXAMINER THEN WITHDREW THE DIAGNOSTIC (DX) CATHETER, AND THE TIP BROKE OFF. THE DISTAL PORTION OF THE CATHETER WAS NOTED TO HAVE SEPARATED, ABOUT 5CMS. THE DEVICE WAS NOTED TO HAVE PUNCTURED AND SEPARATED AT THE SAME LOCATION ON THE CATHETER. IT WAS THEN RETRIEVED FROM THE GROIN WITH THE SNARE. THE PROCEDURE WAS COMPLETED WITH A NEW PIGTAIL CATHETER FROM CORDIS. THE DEVICE WAS REMOVED WITHOUT PATIENT INJURY. THE DEVICE WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO APPARENT DAMAGE NOTED ON THE DEVICE PRIOR TO USE. THERE WAS NO RESISTANCE/ FRICTION WHILE ADVANCING THE DEVICE THROUGH THE VESSEL. UNUSUAL FORCE WAS NOT NEEDED TO ADVANCE OR WITHDRAW THE CATHETER FROM THE PATIENT. THE UNKNOWN LESION WAS NOTED TO HAVE NO CALCIFICATION. THE VESSEL WAS NOT TORTUROUS. A NON-CORDIS .035 150CM WIRE WAS USED WITH THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION. AN ADDITIONAL, STERILE INFINITI PIGTAIL CATHETER WAS RETURNED FOR EVALUATION. THE EVALUATION SHOWS PUNCTU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158379 ↗
• MalfunctionFeb 9, 2024Material Puncture/Hole; Difficult to Remove; Material Puncture/Hole; Difficult to Remove

  AS REPORTED, A 4F 110CM, PIGTAIL 145 DEGREES, 6-SIDEHOLE (SH) MICRO LOOP INFINITI DIAGNOSTIC CATHETER GOT STUCK IN THE RADIAL ARTERY. IT BECAME "UNSTUCK" AND "DOUBLED OVER ITSELF AND BROKE". THE CATHETER DID NOT BREAK APART, HOWEVER, THE CATHETER KINKED ON ITSELF AND THE .035IN WIRE PUNCTURED OUT AT THE KINK. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WAS KEPT IN THE CATH LAB. THE ACCESS SITE AND TARGET SITE VESSEL WERE OF NORMAL ANATOMY. THE DEVICE WAS REMOVED PROPERLY. THE DEVICE WAS TORQUED OR ¿STEERED¿ BY THE HUB. WHEN WITHDRAWING THE DEVICE, THE CATHETER HAD KINKED, AND WHEN THE .035 WIRE WAS ADVANCED IN, IT EXITED AT THE KINK (NOT THE LUMEN). THE CATHETER DID NOT BREAK APART. THE CATHETER BENT OVER ON ITSELF IN THE RIGHT BRACHIAL-CEPHALIC ARTERY. THE DEVICE WAS PROPERLY STORED. THE PATIENT HAD NO ISSUES AND RECEIVED AN INTERVENTION VIA THE SAME RIGHT RADIAL APPROACH. THE CATHETER WILL BE RETURNED FOR EVALUATION. PER IMAGE REVIEW, THE RADIOGRAPHIC IMAGE APPEARS TO DISPLAY A PIGTAIL CATHETER IN THE RIGHT RADIAL ARTERY. THREE KINKED CONDITIONS ARE NOTED TOWARD THE DISTAL END OF THE CATHETER. THE MOST PROXIMAL KINK HAS CAUSED THE DISTAL END OF CATHETER TO FOLD OVER AND P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18677973 ↗