Cook G00166Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002001664), received between Nov 30, 2017 and May 11, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Bent” (1 report).

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

• MalfunctionMay 11, 2026Unsealed Device Packaging

  AS REPORTED, THE PACKAGING OF A ONE-PART PERCUTANEOUS ENTRY NEEDLE WAS NOT SEALED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. UPON RETURN OF THE COMPLAINT DEVICES, FIVE PACKAGES OF THE ONE-PART PERCUTANEOUS ENTRY NEEDLE WERE FOUND TO NOT BE SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142229 ↗
• MalfunctionMay 9, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, A HAIR WAS FOUND INSIDE THE PACKAGE OF A ONE-PART PERCUTANEOUS ENTRY NEEDLE. THE DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14340587 ↗
• MalfunctionOct 24, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 9233026 ↗
• InjuryJan 24, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN AORTOGRAM WITH LEFT LOWER EXTREMITY RUN-OFF, THE ONE-PART PERCUTANEOUS ENTRY NEEDLE WAS FLUSHED AND USED TO GAIN ACCESS TO THE PATIENT'S GROIN. ANOTHER MANUFACTURER'S 0.035 INCH DIAMETER GLIDEWIRE WAS THEN INSERTED THROUGH THE ENTRY NEEDLE AND A SHEARING EFFECT WAS NOTED. PART OF THE GLIDEWIRE WAS DISSECTED BY THE ENTRY NEEDLE; A SLIVER OF MATERIAL WAS RECOVERED FROM THE PATIENT WHEN REMOVING THE ENTRY NEEDLE AND GLIDEWIRE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE; NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.

  Patient problems: No Code Available

  MAUDE report 7215900 ↗
• MalfunctionNov 30, 2017Bent; Bent

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY, THE TIP OF THE ONE-PART PERCUTANEOUS ENTRY NEEDLE WAS BENT AND INCOMPATIBLE WITH THE ASSOCIATED PRODUCT MODEL. ACCORDING TO THE INITIAL REPORTER, THE NEEDLE DID NOT COME INTO CONTACT WITH THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE, NOR DID THE PATIENT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7072543 ↗