ARROW IPN000010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801902066633), received between Aug 31, 2018 and Sep 19, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K112554); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2018Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED "UNCOMPLICATED PUNCTURE OF THE RADIAL ARTERY. DIFFICULTIES TO INSERT THE SHEATH THROUGH THE SKIN. CONSEQUENTLY, SENDING OFF THE TIP AFTER THE INCISION RESISTANCE TO PUSH THE SHEATH. AFTER PUSHING THE SHEATH GUIDEWIRE WAS BROKE." IT WAS REPORTED THAT THE DEVICE WAS REMOVED. ANOTHER DEVICE WAS USED VIA A DIFFERENT ENTRANCE. IT WAS ALSO REPORTED THAT THE PATIENT DID REQUIRE AN INTERVENTION TO REMOVE THE PIECE OF THE GUIDEWIRE THAT BROKE OFF. "THE SURGEON CUT THE SKIN AND VESSEL OPEN TO REMOVE THE DEVICE". PATIENT CURRENT CONDITION REPORTED AS FINE. THERE WAS NO REPORT OF PATIENT DEATH.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7890920 ↗
• MalfunctionSep 4, 2018Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE DILATED TUBE WAS INSERTED INTO THE PATIENT'S RADIAL ARTERY, HOWEVER, THE CATHETER COULD NOT PASS THROUGH THE SHEATH AND HAD TO BE REMOVED. "THE GUIDE CATHETER COULD NOT BE ADVANCED THROUGH THE SHEATH." THERE WAS NO REPORT OF PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7842191 ↗
• MalfunctionSep 4, 2018Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE DILATED TUBE WAS INSERTED INTO THE PATIENT'S RADIAL ARTERY, HOWEVER, THE CATHETER COULD NOT PASS THROUGH THE SHEATH AND HAD TO BE REMOVED. "THE GUIDE CATHETER COULD NOT BE ADVANCED THROUGH THE SHEATH." THERE WAS NO REPORT OF PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7841931 ↗
• MalfunctionAug 31, 2018Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE DILATED TUBE WAS INSERTED INTO THE PATIENT'S RADIAL ARTERY, HOWEVER, THE CATHETER COULD NOT PASS THROUGH THE SHEATH AND HAD TO BE REMOVED. "THE GUIDE CATHETER COULD NOT BE ADVANCED THROUGH THE SHEATH." THERE WAS NO REPORT OF PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7837527 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112554. One submission often covers many models, so check the product and lot details in each record.

• Z-0468-2014 · Oct 9, 2013 · Terminated
  Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and thera