Micropuncture G47942Recalls & reported problems
Cook Incorporated · Micropuncture Introducer Set Silhouette Transitionless With Nitinol Wire Guide · Class 2
All models of Micropuncture (39)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Cook Micropuncture introducer set is a sterile access kit used to guide a wire into a blood vessel during procedures. Most reports describe the wire guide or sheath giving way mid-use — the wire unravelling, fraying, or separating, and the sheath stretching, kinking or bending, plus a few packages found unsealed or stained with no patient involved. There are 36 reports, with no deaths and 7 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00827002479425), received between Feb 2, 2015 and Nov 25, 2025 — classified as 7 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Material Separation” (14 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.
Reports received per month
Most reported problems
Device problems
- Material Separation14
- Unraveled Material11
- Stretched5
- Kinked3
- Material Frayed3
- Bent2
- Break2
- Unsealed Device Packaging2
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Known Impact Or Consequence To Patient10
- No Code Available6
- No Information3
- No Patient Involvement3
- Device Embedded In Tissue or Plaque2
- No Consequences Or Impact To Patient2
- Blood Loss1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2025Unraveled 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 23645383 ↗MalfunctionJan 7, 2025Unsealed Device Packaging; Unsealed Device Packaging
AS REPORTED BY A DISTRIBUTOR, UPON RECEIVING AND INSPECTING A MICROPUNCTURE TRANSITION LESS ACCESS SET, IT WAS NOTED THAT THE STERILE PACKAGING WAS NOT SEALED. BECAUSE THIS WAS FOUND WITHIN A DISTRIBUTION FACILITY, THERE WAS NO IMPACT TO ANY PATIENT OR END USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21095370 ↗MalfunctionNov 26, 2024Unsealed Device Packaging; Unsealed Device Packaging
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 20786254 ↗MalfunctionSep 30, 2024Unraveled Material; Unraveled Material
AS REPORTED, DURING A PROCEDURE INVOLVING Y-90 TREATMENT, A MICROPUNCTURE TRADITIONLESS ACCESS SET'S WIRE UNRAVELED UPON REMOVAL OF THE DEVICE. ULTRASOUND-GUIDED ACCESS WAS OBTAINED IN THE FEMORAL ARTERY, AND BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE, PRIOR TO ADVANCING THE WIRE GUIDE. THE ACCESS SITE WAS NOT SCARRED OR CALCIFIED, AND RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF THE DEVICE. THE WIRE WAS NOT PULLED OR MANIPULATED BACKWARDS THROUGH THE NEEDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20336545 ↗MalfunctionJun 20, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, PRIOR TO PATIENT CONTACT DURING AN UNKNOWN PROCEDURE, THE USER OPENED THE PACKAGE AND NOTED THERE WERE MANY TRACES OF ¿SUSPECTED STAINS¿ INSIDE THE MICROPUNCTURE TRANSITIONLESS ACCESS SET'S STERILE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19578543 ↗MalfunctionApr 9, 2024Unraveled Material; Difficult to Advance; Unraveled Material; Difficult to Advance
AS ORIGINALLY REPORTED, THE WIRE GUIDE INCLUDED IN A MICROPUNCTURE TRANSITIONLESS ACCESS SET WOULD NOT PASS THROUGH THE SHEATH AFTER THE SHEATH ENTERED THE BLOOD VESSEL. ACCESS WAS NOT OBTAINED VIA ULTRASOUND GUIDANCE IN THE POPLITEAL VEIN AND THE ACCESS SITE WAS "NORMAL". RESISTANCE WAS NOT FELT DURING INSERTION OR REMOVAL OF ANY OF THE COMPONENTS. BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE THE WIRE WAS NOT REMOVED OR MANIPULATED BACKWARDS THROUGH THE NEEDLE. ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. UPON RETURN AND INITIAL EVALUATION OF THE COMPLAINT DEVICE, THE WIRE GUIDE WAS UNRAVELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19069349 ↗MalfunctionOct 11, 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 17914628 ↗MalfunctionAug 15, 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 17550930 ↗MalfunctionJul 13, 2023Break; Break
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 17318399 ↗MalfunctionDec 3, 2021Unraveled Material; Unraveled Material
NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12923874 ↗MalfunctionSep 23, 2021Unraveled Material; Unraveled Material
NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12520185 ↗MalfunctionApr 5, 2021Peeled/Delaminated; Peeled/Delaminated
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 11612951 ↗MalfunctionJan 19, 2021Material Frayed; Material Frayed
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 11193963 ↗InjuryJan 11, 2021Material Frayed; Material Separation; Stretched; Material Frayed; Material Separation; Stretched
A MEDWATCH REPORT (MW 5098665) WAS RECEIVED 22JAN2021. THE TIP OF THE WIRE GUIDE BECAME LODGED DURING PORT PLACEMENT, SUBSEQUENTLY STRETCHING AND THINNING. THE SEPARATED TIP REMAINED EMBEDDED IN THE PATIENT. CT IMAGES SHOW THE RETAINED WIRE TIP (EXTRAVASCULAR OR LODGED IN A VERY SMALL VEIN) EXTENDING INFERIORLY INTO THE INFERIOR VENA CAVA.
Patient problems: No Code Available
MAUDE report 11146424 ↗InjurySep 21, 2020Fracture; Material Separation; Fracture; Material Separation
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; No Code Available
MAUDE report 10563673 ↗MalfunctionJul 3, 2019Material Separation; Material Separation
ADDITIONAL INFORMATION AS RECEIVED NOTING THAT THE WIRE WAS NOT MANIPULATED. THE NEEDLE WAS PULLED OUT OF THE PATIENT, WITH THE MICROCATHETER THREADED OVER THE WIRE. WHEN THE DILATOR WAS PULLED BACK, THE WIRE SEPARATED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8757979 ↗MalfunctionMar 11, 2019Material Separation; Stretched; Material Separation; Stretched
IT WAS REPORTED, A PATIENT OF UNSPECIFIED GENDER AND AGE WAS UNDERGOING AN UNSPECIFIED PROCEDURE OF THEIR FOREARM HEMODIALYSIS ACCESS, VESSEL NOT SPECIFIED. INITIAL ADVANCEMENT OF THE WIRE FROM A MICROPUNCTURE TRANSITIONLESS ACCESS SET WAS SUCCESSFUL UNTIL IT REACHED A POINT WHERE ADVANCEMENT WAS NO LONGER POSSIBLE. REPORTEDLY, THE PHYSICIAN WAS ATTEMPTING TO MAKE A SHARP TURN AND KEPT RUNNING INTO A BLOCKAGE OF SOME KIND. THE PHYSICIAN STATED THAT THE VESSEL WAS NOT CALCIFIED, BUT IT'S BEEN PROPOSED THAT IT MAY HAVE BEEN TORTUOUS. MULTIPLE ATTEMPTS TO ADVANCE IT RESULTED IN THE WIRE "TYING ITSELF INTO KNOTS," WHICH MADE IT EXTREMELY DIFFICULT TO REMOVE FROM THE BODY. HOWEVER, WITH FORCE, THE PHYSICIAN WAS FINALLY ABLE TO REMOVE THE DEVICE. A SECOND MICROPUNCTURE TRANSITIONLESS ACCESS SET FROM THE SAME LOT WAS ATTEMPTED WITH THE SAME RESULT. THE PHYSICIAN CHOSE NOT TO PROCEED FURTHER AT THAT TIME. THE PATIENT WAS SCHEDULED FOR A SECOND ATTEMPT AT THE PROCEDURE (B)(6) 2019. 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 AN
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8409690 ↗MalfunctionSep 25, 2018Unraveled Material; Unraveled Material
IT WAS REPORTED, THE WIRE GUIDE OF THE MICROPUNCTURE TRANSITIONLESS ACCESS SET WAS FOUND TO BE KINKED PRIOR TO PATIENT USE. UPON PRELIMINARY VISUAL INSPECTION BY THE MANUFACTURER, THE WIRE GUIDE WAS UNRAVELED. NO PATIENT ADVERSE EFFECTS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 7906995 ↗MalfunctionMay 10, 2018Stretched; Unraveled Material; Stretched; Unraveled Material
IT WAS REPORTED THAT DURING A PERIPHERAL ARTERIOGRAM VIA THE GROIN ACCESS, THE MICROPUNCTURE TRANSITIONLESS ACCESS SET STRETCHED/UNRAVELED AFTER IT WAS REMOVED. THE WIRE WAS SIMULTANEOUSLY REMOVED WITH THE MPIS INTRODUCER WHICH UNRAVELED WHEN THE DEVICE WAS WIPED DOWN USING A 4X4 GAUZE WITH NON HEPARINIZED SALINE SOLUTION. THIS OCCURRED ON THE STERILE TABLE AFTER REMOVAL FROM THE PATIENT. ACCORDING TO THE INITIAL REPORTER, 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.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7502414 ↗MalfunctionMay 10, 2018Material Separation; Material Separation
IT WAS REPORTED THAT AT THE END OF A FISTULAGRAM OF THE LEFT UPPER ARM FISTULA, THE CATHETER TIP ON THE MICROPUNCTURE TRANSITIONLESS ACCESS SET BROKE OFF. THE (B)(6) YEAR OLD FEMALE PATIENT'S ANATOMY WAS REPORTED TO BE CALCIFIED, TORTUROUS, AND/OR SCARRED, BUT ADVANCEMENT OF THE COMPLAINT DEVICE WAS REPORTEDLY NOT DIFFICULT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 7502413 ↗MalfunctionMay 8, 2018Material Separation; Material Separation
IT WAS REPORTED THAT DURING A PORT-O-CATH PLACEMENT PROCEDURE, THE MICROPUNCTURE TRANSITIONLESS ACCESS SET "BROKE" DURING CANNULATION THROUGH THE SKIN. THE COMPLAINT DEVICE WAS REMOVED AND ANOTHER CANNULATION WAS PERFORMED. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7496003 ↗MalfunctionFeb 23, 2018Break; Failure to Advance; Break; Failure to Advance
IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE MICROPUNCTURE TRANSITIONLESS ACCESS SET INTRODUCER WOULD NOT ADVANCE. UPON PULLING BACK THE INTRODUCER, IT BROKE FIVE (5) MILLIMETERS (MM) FROM THE EDGE OF THE HUB. THE PATIENT WAS NOTED TO HAVE A VERY SCARRED NECK; IT WAS THE 15TH PUNCTURE AT THIS POINT ON THE NECK. 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. ADDITIONAL INFORMATION IS NOT AVAILABLE PER THE INITIAL REPORTER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7293139 ↗InjuryDec 29, 2017Material Separation; Material Separation
NO NEW PATIENT OR EVENT INFORMATION SINCE HE LAST REPORT WAS SUBMITTED.
Patient problems: No Code Available
MAUDE report 7155447 ↗MalfunctionNov 9, 2017Unraveled Material; Unraveled Material
IT WAS REPORTED THAT DURING EITHER A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) OR PORT INSERTION, THE MICROPUNCTURE TRANSITIONLESS ACCESS SET WIRE GUIDE UNRAVELLED AS IT WAS REMOVED. THE PHYSICIAN WAS ABLE TO REMOVE THE ENTIRE MICROPUNCTURE TRANSITIONLESS ACCESS SET AND WIRE GUIDE, AND PROCEEDED TO USE ANOTHER SET 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 7013860 ↗MalfunctionJul 27, 2017Kinked; Stretched
THE MICROPUNCTURE CATHETER KINKED DURING INSERTION UPON REMOVAL THE DEVICE STRETCHED. THE DEVICE IN QUESTION WAS ABLE TO BE USED SUCCESSFULLY 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 6748528 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page