Micropuncture G35551Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002355514), received between Aug 18, 2017 and Jan 25, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 25, 2023Contamination /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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16241416 ↗
• InjuryMar 8, 2019Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: Foreign Body In Patient

  MAUDE report 8404269 ↗
• InjuryApr 11, 2018Kinked; Material Separation; Kinked; Material Separation

  IT WAS REPORTED THAT DURING A VENOGRAM WITH A THROMBOLYSIS PROCEDURE THE WIRE PORTION OF THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET MET RESISTANCE AND BECAME KINKED UPON INSERTION. DURING WITHDRAWAL OF THE WIRE THROUGH THE SHEATH, THE DISTAL PORTION OF THE WIRE SHEARED OFF AND WAS RETAINED IN THE PATIENT¿S VEIN. ACCORDING TO INFORMATION RECEIVED, THE PATIENT HAD VERY COMPLICATED ANATOMY WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE SUCCESSFUL REMOVAL OF THE SHEARED PORTION WAS PERFORMED.THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT FOR AN UNSPECIFIED LENGTH OF TIME AND WAS SUBSEQUENTLY DISCHARGED HOME. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE INITIAL INFORMATION WAS RECEIVED VIA USER FACILITY REPORT NUMBER 1316394638-2018-2 THAT WAS EMAILED TO COOK INC. BY THE FACILITY. ADDITIONAL INFORMATION WAS OBTAINED LATER.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 7420803 ↗
• InjuryMar 30, 2018Bent; Material Separation; Difficult to Advance; Bent; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT WHILE ACCESSING THE PATIENT'S ARTERY FOR A LOWER EXTREMITY ANGIOGRAM, ONCE THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET NEEDLE WAS INSIDE OF THE ARTERY, THE SET WIRE GUIDE WAS INSERTED. AS THE WIRE GUIDE WAS BEING MANIPULATED, THE TIP BROKE OFF INSIDE OF THE PATIENT'S ANATOMY. THE STIFFENED CANNULA INTRODUCER THAT GOES OVER THE WIRE GUIDE WAS INSERTED AND THE PHYSICIAN MADE A SKIN KNICK TO ADVANCE. DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING THE INTRODUCER AND IT BENT A FEW TIMES, BUT THE PHYSICIAN WAS ABLE TO ADVANCE IT. UPON REMOVAL OF THE INTRODUCER, THE TIP WAS WITHIN THE INTRODUCER; HOWEVER, WHEN THE INTRODUCER WAS PULLED OUT, THE TIP REMAINED INSIDE THE PATIENT ON THE NEEDLE TRACK. THE TIP WAS THEN ABLE TO BE GRABBED AND PULLED OUT OF THE PATIENT. A NEW SET WAS OPENED AND UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT ANATOMY HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 7384725 ↗
• InjuryAug 18, 2017Kinked; Material Separation; Kinked; Material Separation

  ADDITIONAL INFORMATION PROVIDED BY THE MANUFACTURER REPRESENTATIVE, THE COAXIAL CATHETER FROM THE COMPLAINT DEVICE SET WAS DAMAGED AND BECAME KINKED UPON INSERTION. NO UNINTENDED SECTION OF THIS DEVICE REMAIN INSIDE THE PATIENT¿S BODY.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6805270 ↗