CrossCath G51577Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002515772), received between Aug 3, 2016 and Mar 31, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 8, 2019Terminated

   A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).

   Z-0590-2020 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2022Break; Peeled/Delaminated; Break; Peeled/Delaminated

  AS REPORTED, A CROSSCATH SUPPORT CATHETER DELAMINATED. THE DEVICE WAS ATTEMPTED TO BE ADVANCED OVER A 0.018" WIRE GUIDE BUT COULD NOT DUE TO RESISTANCE. THE CATHETER BUNCHED, AND A FRAGMENT SEPARATED FROM THE CATHETER WHEN REMOVING FROM THE WIRE. THE DEVICE DID NOT MAKE PATIENT CONTACT. 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 13967422 ↗
• MalfunctionFeb 20, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A VASCULAR CASE, CONTRAST WAS LEAKING FROM THE SIDE OF THE CROSSCATH SUPPORT CATHETER DURING INJECTION. NO BLOOD LOSS WAS NOTED. 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 7282730 ↗
• MalfunctionJul 18, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A LOWER LEG ANGIOGRAM PROCEDURE, THE WIRE BECAME STUCK AND GRABBED TISSUE DURING REMOVAL VIA THE CROSSCATH SUPPORT CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6723642 ↗
• MalfunctionMay 12, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LEFT LEG ANGIOGRAM, A V18 GUIDE WIRE WAS USED INSIDE A CROSSCATH SUPPORT CATHETER TO ADVANCE THROUGH THE LESION TOWARD THE TARGET AREA. THE PHYSICIAN NOTICED BUCKLING OF THE CATHETER AND DECIDED TO EXCHANGE CATHETERS. WHEN PULLING THE CROSSCATH SUPPORT CATHETER BACK OUT OF THE PATIENT, THE CATHETER WOULD NOT SLIDE BACK OVER THE WIRE; THEY WERE ESSENTIALLY STUCK TOGETHER. IN ORDER TO MAINTAIN PURCHASE WITH THE WIRE, A PORTION OF THE CATHETER WAS CUT OPEN AND PEALED BACK IN AN ATTEMPT TO SEPARATE THE TWO. HOWEVER, THAT IS WHEN THEY NOTICED THE ACCORDION-LIKE EFFECT ON THE CATHETER. EVENTUALLY BOTH THE WIRE AND CATHETER WERE REMOVED FROM THE PATIENT TOGETHER. THE DEVICE WAS RETURNED TO THE MANUFACTURER; UPON INSPECTION, IT WAS FOUND TO BE SEPARATED AT THE STRAIN RELIEF. 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 6563112 ↗
• InjuryAug 3, 2016Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE INITIAL ACCESS OF THE CHOSEN CATHETER SITE WAS TOO DIFFICULT AND THE PHYSICIAN HAD TO MOVE TO THE OTHER LEG. HOWEVER, THERE WAS DIFFICULTY LOADING THE CATHETER ONTO THE WIRE AND PLACEMENT WAS ABORTED. DURING THE REMOVAL PROCESS, WHEN ATTEMPTING TO REMOVE THE CATHETER OFF THE WIRE, THE CATHETER LOCKED ON THE WIRE AND BROKE INTO THREE PIECES. REPORTEDLY NONE OF THE CATHETER BROKE OFF IN THE PATIENT. THE PHYSICIAN REMOVED THE WIRE AND CATHETER OUT OF THE SHEATH AND PUT IN A NEW WIRE TO COMPLETE THE PROCEDURE. THE WIRE TORE THE NURSE¿S GLOVE AND SCRAPED HER HAND BUT THE CUSTOMER DID NOT CONFIRM IF ANY MEDICAL ATTENTION WAS ADMINISTERED, AS THIS WOULD DEPEND ON FACILITY PROTOCOL. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY AND THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Injury

  MAUDE report 5842622 ↗