Micropuncture G43871Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002438712), received between Jun 13, 2018 and Feb 26, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2025Break; Break

  AS REPORTED, DURING AN UNKNOWN PROCEDURE VIA ACCESS IN THE FEMORAL ARTERY, THE TIP OF A MICROPUNCTURE TRANSITIONLESS ACCESS SET¿S WIRE SEPARATED IN A PATIENT DURING INSERTION OF THE DEVICE. THE ACCESS SITE WAS REPORTEDLY CALCIFIED. THE SEPARATED TIP WAS RETRIEVED FROM THE PATIENT VIA CUT-DOWN OF THE FEMORAL ARTERY. PER THE REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472321 ↗
• MalfunctionMar 24, 2023Unraveled Material; Unraveled Material

  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 16613854 ↗
• MalfunctionJan 19, 2023Unraveled Material; Unraveled Material

  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 16205434 ↗
• MalfunctionOct 14, 2022Unraveled Material; Unraveled Material

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

  Patient problems: Insufficient Information

  MAUDE report 15605929 ↗
• MalfunctionJun 9, 2022Unraveled Material; Unraveled Material

  AS REPORTED, DURING A PROCEDURE INVOLVING PLACEMENT OF AN ARTERIAL LINE, A MICROPUNCTURE TRADITIONLESS ACCESS SET'S WIRE "SHREDDED" UPON WITHDRAWAL OF THE WIRE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14644810 ↗
• MalfunctionJan 28, 2021Unraveled Material; Unraveled Material

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11243068 ↗
• InjuryDec 18, 2018Material Separation; Material Separation

  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 8173977 ↗
• MalfunctionSep 19, 2018Material Integrity Problem; Material Integrity Problem

  AN (B)(6) MALE WITH PAST MEDICAL HISTORY OF DIABETES (TYPE NOT SPECIFIED), MALIGNANT NEOPLASM OF THE PANCREAS, CEREBROVASCULAR ACCIDENT (TYPE AND DATE NOT SPECIFIED), AND AORTIC STENOSIS UNDERWENT A PROCEDURE TO INSERT A MEDIPORT. PATIENT'S ANATOMY WAS NEITHER SCARRED, TORTUOUS, OR CALCIFIED. UPON REMOVAL OF THE GUIDEWIRE FROM THE SHEATH OF THE MICROPUNCTURE TRANSITIONLESS ACCESS SET, IT REPORTEDLY SHREDDED INTO STRANDS. THERE WAS NO DIFFICULTY ON INSERTION OF THE COMPLAINT DEVICE. NO RETAINED OBJECTS WERE SEEN UPON FLUOROSCOPY OF THE PATIENT'S CHEST AFTER THE OCCURRENCE OF THE EVENT. NO PATIENT ADVERSE EFFECTS WERE REPORTED. THE PATIENT'S OUTCOME WAS REPORTEDLY FAVORABLE. NO ADDITIONAL PROCEDURES WERE REQUIRED. MEDICATIONS ADMINISTERED DURING THE PROCEDURE WERE AS FOLLOWS: BACITRACIN FOR TOPICAL IRRIGATION OF MEDIPORT IMPLANT, MARCAINE 0.5% MIXED WITH LIDOCAINE 1% (15 ML GIVEN INTRADERMALLY TO INCISION SITE), 2G OF ANCEF FOR INTRAOPERATIVE ANTIBIOTIC, AND HEPARIN LOCK FLUSH (12ML USED TO FLUSH MEDIPORT CATHETER AT END OF CASE). ACCORDING TO THE INITIAL REPORTER, IT IS NOT CLEAR IF THE COMPLAINT DEVICE WILL BE RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7891480 ↗
• MalfunctionAug 3, 2018Material Separation; Material Separation

  IT WAS REPORTED, DURING A DEVICE FAILURE ANALYSIS OF THE MICROPUNCTURE TRANSITIONLESS ACCESS SET THAT A PARTIAL SEPARATION OCCURRED. THE ORIGINAL INCIDENT WAS NOTED AS DIFFICULT ADVANCEMENT OF THE DEVICE IN AN UNSPECIFIED PROCEDURE. AFTER REMOVING THE FIRST DEVICE, ANOTHER DEVICE WAS USED AND NO FURTHER ISSUES WERE REPORTED. HOWEVER, AFTER MANUFACTURER EVALUATION, IT WAS DETERMINED THAT THE COILS APPEARED "PUSHED AWAY" FROM THE SOLDER CONNECTION BETWEEN THE MANDRILL AND COIL. 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 7746805 ↗
• MalfunctionJun 13, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED, A HAIR WAS NOTED WITHIN THE STERILE PACKAGE OF A MICROPUNCTURE TRANSITIONLESS ACCESS SET PRIOR TO USE. THE COMPLAINT DEVICE WAS NOT USED. A DIFFERENT SET WAS OPENED AND USED TO BEGIN THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, NO PATIENT ADVERSE EVENTS WERE EXPERIENCED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7598108 ↗