Micropuncture G56201Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00827002562011), received between Jun 15, 2016 and Mar 11, 2024 — classified as 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2024Break; Break

  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 18878682 ↗
• MalfunctionNov 17, 2023Unraveled Material; Difficult to Advance; Unraveled Material; Difficult to Advance

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A MICROPUNCTURE TRANSITIONLESS ACCESS SET'S WIRE UNRAVELED. WHILE OBTAINING ACCESS THROUGH FEMORAL ARTERY, THE WIRE WAS DIFFICULT TO ADVANCE THROUGH THE NEEDLE. THE USER REMOVED THE WIRE FROM THE PATIENT AND THE WIRE WAS UNRAVELED/UNCOILED. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 18160062 ↗
• InjuryOct 24, 2023Break; Unraveled Material; Break; Unraveled Material

  ADDITIONAL INFORMATION WAS RECEIVED 07NOV2023. ULTRASOUND GUIDED ACCESS WAS OBTAINED IN THE INTERNAL JUGULAR VEIN. NORMAL BLOOD RETURN WAS NOTED UPON INSERTION OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994905 ↗
• MalfunctionAug 15, 2023Unraveled Material; Material Protrusion/Extrusion; Unraveled Material; Material Protrusion/Extrusion

  AS REPORTED, DURING A SAFARI (SUBINTIMAL ARTERIAL FLOSSING WITH ANTEGRADE-RETROGRADE INTERVENTION) CASE, A MICROPUNCTURE TRANSITIONLESS ACCESS SET'S WIRE UNRAVELED. REPORTEDLY, THE CUSTOMER USED THE MICROPUNCTURE NEEDLE AS USUAL AND PER THE IFU; HOWEVER, THE WIRE UNRAVELED. 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. PER THE CUSTOMER, ADDITIONAL INFORMATION WILL NOT BE PROVIDED. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE WIRE WAS UNRAVELED AND THE INNER SAFETY WIRE PROTRUDED FROM THE COILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17551970 ↗
• InjuryMar 22, 2023Break; Unraveled Material; Break; Unraveled Material

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE WIRE INCLUDED IN A MICROPUNCTURE TRANSITIONLESS ACCESS SET SEPARATED. REPORTEDLY, THE WIRE BROKE LENGTHWISE AND A THIN THREAD OF WIRE REMAINED IN THE PATIENT. THE FRAGMENT WAS EVENTUALLY REMOVED SAFELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592928 ↗
• MalfunctionOct 25, 2021Contamination; Contamination

  NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12688484 ↗
• InjuryJul 2, 2021Material Separation; Material Separation

  AS REPORTED, DURING A ROUTINE DECLOT OF DIALYSIS FISTULA, THE MICROPUNCTURE TRANSITIONLESS ACCESS SHEATH SHEARED OFF INTO THE FISTULA. AFTER MULTIPLE ATTEMPTS TO REMOVE THE MICROPUNCTURE SHEATH, THE SHEATH EVACUATED THE FISTULA AREA AND WAS LODGED IN THE SUPERIOR VENA CAVA AND RIGHT ATRIUM. THE MICROPUNCTURE THEN MOVED INTO THE PULMONARY ARTERY. IT WAS UNABLE TO BE REMOVED. THE PATIENT WAS TRANSFERRED TO A TERTIARY FACILITY. ADDITIONAL PATIENT OUTCOME AND EVENT DETAILS HAVE BEEN REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12107100 ↗
• InjuryJun 2, 2020Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Code Available

  MAUDE report 10111245 ↗
• InjuryApr 13, 2020Material Separation; Material Separation

  AS REPORTED, DURING PLACEMENT OF A TUNNELED DIALYSIS CATHETER, USING A MICROPUNCTURE TRANSITIONLESS ACCESS SET , A PORTION OF THE 0.018 WIRE SEPARATED AND REMAINS IN THE SUBCUTANEOUS TISSUE OF THE LEFT CHEST. THERE ARE NO PLANS TO REMOVE THE WIRE. THERE HAS BEEN NO REPORT THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9952838 ↗
• MalfunctionFeb 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9720113 ↗
• MalfunctionOct 16, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THE MICROPUNCTURE TRANSITIONLESS ACCESS SET WAS BEING USED DURING A PROCEDURE USING VERITHENA TO TREAT A VARICOSE VEIN WHEN THE WIRE GUIDE SPLINTERED IN THE PATIENT'S ANATOMY. THERE WAS NO ISSUE NOTED WITH THE DEVICE DURING IT'S PREPARATION PRIOR TO THE PROCEDURE. THE PHYSICIAN HAD DIFFICULTY REMOVING THE WIRE GUIDE AFTER INSERTING THE MICRO PUNCTURE CATHETER INTO THE PATIENT'S ANATOMY. UPON REMOVAL IT WAS NOTED THE WIRE GUIDE HAD SPLINTERED BUT REMAINED INTACT. AFTER REMOVAL, ANOTHER MICROPUNCTURE TRANSITIONLESS ACCESS SET WAS USED TO COMPLETE THE PROCEDURE. 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 7971163 ↗
• InjuryJun 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, A FEMALE PATIENT IN HER "EARLY 60'S" WITH A NON-HEALING, LEFT FOOT, VASCULAR ULCER, UNDERWENT A STENT PLACEMENT (SITE NOT SPECIFIED) ON (B)(6) 2018 IN AN OUTPATIENT FACILITY. MULTIPLE COOK PRODUCTS WERE USED. ON (B)(6) 2018, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A FEVER (TEMPERATURE UNKNOWN TO COMPLAINANT) AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS DIAGNOSED WITH SEPSIS WHICH WAS TREATED WITH "FLUIDS AND IV ANTIBIOTICS" AND IS "DOING FINE". REPORTEDLY, LAB RESULTS INDICATE A STRAIN OF STREP WAS IDENTIFIED, HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED. PER THE COMPLAINANT: "SEVERAL COOK PRODUCTS WERE INVOLVED WITH ORIGINAL PROCEDURE, UNKNOWN AND NOT ALLEGED AT THIS TIME IF ANY OF THEM MAY HAVE CONTRIBUTED TO THIS." ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND RELEVANT MEDICAL HISTORY HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME. PLEASE REFERENCE ADDITIONAL MEDWATCH NUMBERS REGARDING ALL COOK PRODUCTS IN USE DURING THE PROCEDURE: CID-20-30-NG (1820334-2018-01470), KCFW-5.0-38-RB (1820334-2018-01613), KCFW-6.0-18/38-45-RB-ANL0-HC (1820334-2018-01614), MPIS-402-NT-U-SST (1820334-2018-01615) THIS REPORT, PTA5-35-135

  Patient problems: Sepsis

  MAUDE report 7634233 ↗
• MalfunctionOct 17, 2017Material Separation; Material Separation

  A MICROPUNCTURE TRANSITION LESS ACCESS SET WAS USED IN AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT WHEN THE INTERVENTIONIST WAS GAINING ACCESS WITH THE PRODUCT, THE SHEATH CAME APART FROM THE HUB. 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 6954866 ↗
• MalfunctionAug 16, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED PRIOR TO AN UNSPECIFIED PROCEDURE, A PARTICLE WAS NOTED IN THE SEALED PACKAGE OF A MICROPUNCTURE TRANSITIONLESS ACCESS SET. ANOTHER DEVICE WAS USED FOR THE PROCEDURE. NO ADVERSE EFFECTS TO A PATIENT AS THE DEVICE DID NOT MAKE CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6798341 ↗
• InjuryAug 12, 2016Break; Break

  IT WAS REPORTED THAT DURING AN INTRA JUGULAR DIALYSIS LINE PROCEDURE, THE OPERATOR WAS EXPERIENCING SOME DIFFICULTY PLACING THE CATHETER USING A MICRO-PUNCTURE KIT TO GAIN ACCESS, SO THE DECISION WAS MADE TO EXCHANGE THE KIT FOR A LARGER BORE CATHETER. ANOTHER MANUFACTURER'S WIRE WAS INSERTED INTO THE INTRODUCER AND A SCALPEL WAS USED NEAR THE HUB TO ENLARGE THE ACCESS POINT. REPORTEDLY THE CATHETER INTEGRITY FAILED AND THE CATHETER REMNANT CAME ADRIFT, THE POSITION OF THE CATHETER HUB IN RELATION TO THE SCALPEL DOES NOT SUPPORT THE ASSUMPTION THAT THE CATHETER WAS DAMAGED AT THIS POINT, ALTHOUGH IT IS ACCEPTED THAT THIS WAS A POSSIBILITY. THE CATHETER MAY HAVE BEEN NICKED WITH A SCALPEL , BUT NOT COMPLETELY CUT AS THERE WAS A WIRE THROUGH THE INTRODUCER AT THE TIME. THE DETACHED SECTION OF THE CATHETER WAS UNABLE TO BE REMOVED AND REMAINS IN-SITU. CT AND MR IMAGINING WAS USED TO IDENTIFY THAT THE MICRO-PUNCTURE CATHETER FRAGMENT LOCATION WAS WITHIN THE RIGHT BRACHIOCEPHALIC VEIN. IT HAS BEEN FURTHER REPORTED THERE ARE NO PLANS TO REMOVE THE CATHETER FRAGMENT, THE PATIENT REPORTEDLY HAS A PRE-EXISTING STENT IN THE BRACHIOCEPHALIC VEIN AND IT APPEARS THAT THE CATHETER SEGMENT IS LOD

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5871519 ↗
• InjuryJun 15, 2016Break; Break

  IT WAS REPORTED THAT DURING A RADIOLOGY PROCEDURE, A MICRO-PUNCTURE KIT THAT WAS BEING USED TO GAIN ACCESS TO THE LEFT INTERNAL JUGULAR VEIN, FRACTURED WHILE BEING USED. FLUOROSCOPIC CONTROL BEING USED DURING THE PROCEDURE CONFIRMED THE FRACTURE OF THE DEVICE. THE COMPONENT WAS IN THE LEFT INTERNAL JUGULAR VEIN AND WAS POSITIONED OVER A GUIDE WIRE. THE PART ATTACHED TO THE OUTER HUB WAS REMOVED AND THE RETAINED PART WAS RETRIEVED FROM THE VESSEL USING A SNARE WIRE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5726034 ↗