Micropuncture G56202Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002562028), received between Jul 18, 2017 and Feb 10, 2021 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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.

• MalfunctionFeb 10, 2021Material Separation; Material Separation

  AS REPORTED, A MICROPUNCTURE TRADITIONLESS ACCESS SET'S WIRE SHEARED WHILE OBTAINING ACCESS FOR FEMORAL LINE PLACEMENT. THE USER REPORTED THAT THE WIRE WAS NOT AS SMOOTH AS NORMAL AT THE DISTAL TIP. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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; No Consequences Or Impact To Patient

  MAUDE report 11306935 ↗
• InjuryJun 11, 2018Material Separation; Material Separation

  IT WAS REPORTED, DURING A THROMBECTOMY OF A FISTULA, THE WIRE OF THE MICROPUNCTURE TRANSITIONLESS ACCESS SET "FELL APART" WHERE IT MEETS THE FLOPPY END. THERE WAS NO CALCIFICATION, SCARRING, TORTUOUS ANATOMY NOR WAS THERE ANGULATION OF THE PATIENT'S ANATOMY REPORTED. THE SEPARATED DEVICE PORTION WAS SNARED AND SUCCESSFULLY REMOVED FROM THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUE. 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 Code Available

  MAUDE report 7587905 ↗
• InjuryMay 31, 2018Material Separation; Material Separation

  AN SUS VOLUNTARY EVENT REPORT (MW5077214) WAS RECEIVED WHICH REPORTED THE DISTAL TIP OF THE MICROPUNCTURE TRANSITIONLESS ACCESS SET SEPARATED AND A PORTION REMAINED IN THE PATIENT'S ANATOMY. IT WAS REPORTED THE PATIENT WAS STATUS POST-HEART TRANSPLANT AND UNDERWENT A PLANNED RIGHT HEART CATHETERIZATION. THE WIRE OF THE MICROPUNCTURE TRANSITIONLESS ACCESS SET WAS ADVANCED INTO THE INFERIOR VENA CAVA. MULTIPLE ATTEMPTS TO ADVANCE THE COMPLAINT DEVICE'S DILATOR AND SHEATH WERE UNSUCCESSFUL. ADDITIONAL ATTEMPTS WERE MADE AFTER REMOVING SCAR TISSUE, BUT WERE STILL UNABLE TO ADVANCE THE CATHETER. AFTER COMPRESSING THE AREA TO TRY TO ADVANCE THE COMPLAINT DEVICE FURTHER AND WITHDRAWING IT, THE PROXIMAL SHAFT CAME BACK, BUT THE DISTAL FRAGMENT WAS NOT PRESENT. UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE CATHETER TIP; THEREFORE, THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY WHERE THE FIVE CENTIMETER (CM) CATHETER TIP WAS REMOVED. THE PATIENT WAS REPORTED IN STABLE CONDITION WITH NO ASSOCIATED COMPLICATIONS. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME IS UNABLE TO BE REQUESTED BECAUSE FACILITY AND INITIAL REPORTER INFORMATION WAS NOT PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7558468 ↗
• InjuryAug 31, 2017Material Separation; Material Separation

  A MICROPUNCTURE TRANSITIONLESS ACCESS SET WAS USED IN A RIGHT LOWER EXTREMITY INTERVENTION. IT WAS REPORTED THAT, THE MICROPUNCTURE SET WAS USED TO GAIN LEFT GROIN ACCESS AND THEN WIRE WAS INSERTED. THE PHYSICIAN WAS NOT SURE IF THE WIRE WAS WITHIN THE LUMEN AND PULLED OUT THE WIRE. DURING FLUOROSCOPY, THE WIRE WAS OBSERVED TO HAVE SHEARED OFF. THE NEEDLE WAS REMOVED AND PRESSURE WAS HELD ON THE GROIN TO CLOSE THE NEEDLE HOLE. RIGHT GROIN ACCESS WAS GAINED IN ORDER TO RETRIEVE THE PIECE OF WIRE THAT SHEARED OFF USING A SNARE. AS THE PHYSICIAN WAS UNABLE TO COMPLETE THE INTENDED PROCEDURE, THE PATIENT WILL RETURN IN APPROXIMATELY TWO WEEKS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY OTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6834107 ↗
• MalfunctionJul 18, 2017Stretched

  IT WAS REPORTED THAT DURING AN AORTOGRAM WITH RUN-OFF, THE MICROPUNCTURE INTRODUCER STRETCHED TO ABOUT 4X ITS NORMAL LENGTH WHILE THE FACILITY WAS USING IT IN THE PATIENTS FOOT. 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 6722090 ↗