CrossCath G51574Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002515741), received between Nov 15, 2016 and Jun 15, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Perforation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2022Material Perforation; Material Perforation

  AS REPORTED, DURING AN ANGIOPLASTY PROCEDURE, AN UNSPECIFIED CTO WIRE PERFORATED A CROSSCATH SUPPORT CATHETER, MAKING A HOLE IN THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14702472 ↗
• MalfunctionFeb 24, 2020Material Perforation; Material Perforation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient; Vascular Dissection

  MAUDE report 9746083 ↗
• MalfunctionMar 15, 2019Material Perforation; Material Perforation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8426093 ↗
• MalfunctionMar 6, 2019Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8395609 ↗
• MalfunctionNov 2, 2017Break

  THE WIRE WAS USED TO GET THROUGH A CHRONIC TOTAL OCCLUSION UPON ADVANCEMENT, THE WIRE PUNCTURED THROUGH CATHETER. THE TIP OF CATHETER WAS ATTACHED BUT WAS HANGING OFF. THE DEVICE WAS REMOVED AND A CATHETER WAS NO LONGER NEEDED AND THE PROCEDURE CONTINUED AS INTENDED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6995805 ↗
• MalfunctionNov 1, 2017Stretched

  CATHETER WAS VISIBLY STRETCHED/THINNED AT THE HUB, STRAIGHT FROM THE PACKAGE, PRIOR TO PATIENT USE. THE PHYSICIAN CHOSE TO USE THE CATHETER ANYWAY AND ONCE HE CROSSED THE LESION, THE PROCEDURE WAS FINISHED AS USUAL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6992663 ↗
• MalfunctionNov 15, 2016Break; Break

  INFORMATION INITIALLY PROVIDED ON (B)(6) 2016 STATED: "SNAPPED IN TWO DURING PEDAL CASE." ADDITIONAL INFORMATION WAS REQUESTED ON (B)(6) 2016. THE COMPLAINT PRODUCT WAS RECEIVED (B)(6) 2016 AND IT WAS NOTED THAT THE DISTAL END OF THE CATHETER WAS MISSING. ADDITIONAL INFORMATION WAS AGAIN REQUESTED (B)(6) 2016 AND WAS INFORMED THE PHYSICIAN WAS OUT OF THE COUNTRY. A RESPONSE WAS PROVIDED (B)(6) 2016 AND IT WAS AT THAT TIME, THE EVENT WAS DETERMINED REPORTABLE. ALTHOUGH THE CUSTOMER DID NOT STATE THE CATHETER SNAPPED WITHIN THE PATIENT, THE MANUFACTURER WAS ADVISED THAT DURING A PERIPHERAL LEG-PEDAL ACCESS AND FEMORAL ARTERY ACCESS PROCEDURE ON THE (B)(6) MALE PATIENT, WITH SEVERE CALCIFIED ARTERY AND PRE-EXISTING CONDITION OF PAD, THE DEVICE "SNAPPED IN TWO." THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6101711 ↗