Micropuncture G43869Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002438699), received between Jun 19, 2019 and Nov 3, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED VIA MEDWATCH REPORT MW5104896 ON 10NOV2021. THE PROCEDURE INVOLVED PLACEMENT OF A TUNNELED HEMODIALYSIS CATHETER. WHEN THE HUB SEPARATED, THE CATHETER BECAME A FOREIGN OBJECT IN THE RIGHT INTERNAL JUGULAR VEIN; HOWEVER, THE DEVICE WAS SNARED AND REMOVED ENTIRELY VIA THE RIGHT FEMORAL VEIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745765 ↗
• InjuryFeb 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE HUB OF A MICROPUNCTURE TRANSITIONLESS ACCESS SET CATHETER, WHICH WAS USED FOR MONITORING OF ARTERIAL PRESSURE DURING A PROCEDURE INVOLVING SURGICAL REMOVAL OF A NECROTIC PENIS, SEPARATED AS THE WIRE GUIDE AS REMOVED. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERTENSION, TYPE II DIABETES, ATHEROSCLEROSIS, AN ISCHEMIC MYOCARDIAL INFARCTION, AORTIC STRICTURE, KIDNEY DISEASE WITH ANURIA, AND EXTREME CALCIFICATION OF THE ARTERIES. THE PATIENT'S BODY MASS INDEX WAS REPORTEDLY OVER 40 KG/MM2. THE ANESTHESIOLOGIST HAD REPORTEDLY ATTEMPTED VASCULAR ACCESS WITH OTHER UNKNOWN MANUFACTURERS' DEVICES BUT WAS UNSUCCESSFUL. THE EXTREMELY SEVERE CALCIFIED ARTERIES AND CALCIFIED ACCESS SITES CAUSED DIFFICULTY ACCESSING THE VESSELS AND FEEDING THE GUIDE WIRE. THE USER THEN GAINED ACCESS IN THE RIGHT BRACHIAL ARTERY WITH THE COMPLAINT DEVICE, USING ULTRASOUND GUIDANCE. THIS ACCESS SITE WAS NOT REPORTED TO BE CALCIFIED OR SCARRED, AND RESISTANCE WAS NOT ENCOUNTERED. THE USER REPORTED THAT PLACEMENT WAS SMOOTH AND THE WIRE WAS MOBILE THROUGHOUT THE PLACEMENT PROCESS. AS THE USER REMOVED THE WIRE GUIDE FROM THE CATHETER, THE HUB SEPARATED. THE INTRODUCER REMAINED INTACT. PER THE USER, NO

  Patient problems: No Code Available

  MAUDE report 9688084 ↗
• InjuryDec 19, 2019Fracture; Fracture

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

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9495389 ↗
• InjuryJun 19, 2019Material Separation; Unraveled Material; Material Separation; Unraveled Material

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

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8713539 ↗