Micropuncture G48004Recalls & reported problems
Cook Incorporated · Micropuncture Introducer Set Silhouette Transitionless Push-Plus Design - STIFFENED CANNULA 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 catheter-based access set with a stiffened cannula and nitinol wire guide, used to reach blood vessels, including during valve replacement and angiogram procedures. The 52 reports mostly describe the sheath or outer catheter separating, breaking or splitting during insertion or removal, and the wire guide unravelling or stretching at its tip. Some describe the needle loosening at the hub. Eleven reports involved an injury, such as a foreign body left in the patient, and no deaths were reported. 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
- 52
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00827002480049), received between May 5, 2016 and Dec 16, 2025 — classified as 11 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Material Separation” (13 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 Separation13
- Break10
- Stretched9
- Unraveled Material8
- Detachment of Device or Device Component7
- Material Split, Cut or Torn4
- Device Damaged Prior to Use3
- Difficult to Remove3
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Consequences Or Impact To Patient9
- No Known Impact Or Consequence To Patient9
- No Code Available6
- Foreign Body In Patient5
- No Patient Involvement4
- Insufficient Information2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2025Break; Unraveled Material; Break; 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 23817044 ↗MalfunctionSep 30, 2025Break; 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 23183567 ↗MalfunctionJun 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING A TRANS-AORTIC VALVE REPLACEMENT PROCEDURE, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET¿S OUTER CATHETER/SHEATH BROKE AT THE HUB UPON INSERTION OF THE DEVICE. THE FEMORAL ACCESS SITE WAS REPORTEDLY NORMAL. ACCESS WAS OBTAINED USING ULTRASOUND GUIDANCE, AND BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF ANY DEVICE COMPONENT, AND THE DEVICE WAS NOT ADVANCED OR REMOVED THROUGH A PREVIOUSLY PLACED VASCULAR CLOSURE DEVICE. THE SEPARATED CATHETER/SHEATH SHAFT WAS MANUALLY REMOVED FROM THE PATIENT. 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 22332083 ↗MalfunctionApr 28, 2025Unraveled Material; Unraveled Material
AS REPORTED, PRIOR TO USE FOR AN UNKNOWN PROCEDURE, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET¿S WIRE GUIDE WAS FOUND TO BE UNRAVELED. PER THE REPORTER, APPROXIMATELY 1.5-CENTIMETERS OF THE WIRE TIP WAS UNRAVELED AND ELONGATED UPON OPENING THE DEVICE PACKAGE. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. 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 21919951 ↗InjuryApr 18, 2025Break; Break
AS REPORTED, WHILE OBTAINING ROUTINE ACCESS FOR AN ANGIOGRAM WITH POTENTIAL EMBOLIZATION, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET¿S SHEATH SEPARATED. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY, AND THE ACCESS SITE WAS NORMAL. THE INTRODUCER WAS NOT ADVANCED OR REMOVED THROUGH A PREVIOUSLY PLACED CLOSURE DEVICE. UPON REMOVAL OF THE DEVICE, RESISTANCE WAS ENCOUNTERED, AND APPROXIMATELY HALF OF THE SHEATH SEPARATED IN THE PATIENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE SEPARATED FRAGMENT VIA A CUT-DOWN OF THE RIGHT GROIN; HOWEVER, THE FRAGMENT WAS NOT RETRIEVED; THEREFORE, ACCESS WAS OBTAINED IN THE LEFT FEMORAL ARTERY AND THE FRAGMENT, WHICH REMAINED ON THE WIRE GUIDE, WAS SUCCESSFULLY RETRIEVED WITH A SNARE. ANOTHER MICROPUNCTURE KIT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT ISSUE. 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. UPON RETURN OF THE COMPLAINT DEVICE, THE SHEATH WAS SEPARATED AND ELONGATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21866319 ↗MalfunctionMar 5, 2025Break; Break
AS REPORTED, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S OUTER SHEATH SEPARATED. THE RIGHT GROIN ACCESS SITE WAS REPORTEDLY SCARRED AND CALCIFIED. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OF THE DEVICE. IT IS UNKNOWN IF THE SHEATH WAS ADVANCED THROUGH A PREVIOUSLY PLACED VASCULAR CLOSURE DEVICE. THE USER ATTEMPTED TO REMOVE THE OUTER SHEATH, OVER AN UNSPECIFIED WIRE, FOR SHEATH EXCHANGE; HOWEVER, RESISTANCE WAS ENCOUNTERED, AND THE MIDDLE OF THE OUTER SHEATH SEPARATED UPON REMOVAL. THE SEPARATED FRAGMENT WAS REMOVED BY HAND. 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 21525093 ↗MalfunctionDec 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING AN UNKNOWN PROCEDURE, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S ACCESS NEEDLE WAS LOOSE AT THE HUB. THE USER ATTEMPTED TO INSERT THE NEEDLE INTO THE FEMORAL ARTERY TO THE SUPERFICIAL FEMORAL ARTERY ONE TIME; HOWEVER, IT REPORTEDLY "DIDN'T WORK" AND RESISTANCE WAS ENCOUNTERED, SO THE NEEDLE WAS REPLACED WITH ANOTHER DEVICE OF THE SAME TYPE TO COMPLETE THE PROCEDURE. THE DEVICE PACKAGE WAS NOT DAMAGED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20866914 ↗MalfunctionAug 28, 2024Unraveled Material; Unraveled Material
AS REPORTED, DURING FIVE DIFFERENT ANTEGRADE OR RETROGRADE RUNOFF PROCEDURES, FIVE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S WIRES UNRAVELED. ACCESS WAS OBTAINED THROUGH THE GROIN. PRIOR TO INTRODUCTION OF THE MICROPUNCTURE SHEATH, THE WIRE WAS REMOVED THROUGH THE NEEDLE AND THE TIP OF THE WIRE "CATCHES ON THE BEVEL OF THE NEEDLE", CAUSING IT TO ELONGATE. RESISTANCE WAS FELT UPON REMOVAL OF THE WIRE AND NO KINKING WAS NOTED. THE DEVICE WAS REMOVED AND A NEW SAME TYPE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURES. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENTS DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THESE OCCURRENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20090430 ↗MalfunctionAug 28, 2024Unraveled Material; Unraveled Material
AS REPORTED, DURING AN ANTEGRADE OR RETROGRADE RUNOFF PROCEDURE, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S WIRE UNRAVELED. ACCESS WAS OBTAINED THROUGH THE GROIN. PRIOR TO INTRODUCTION OF THE MICROPUNCTURE SHEATH, THE WIRE WAS REMOVED THROUGH THE NEEDLE AND THE TIP OF THE WIRE "CATCHES ON THE BEVEL OF THE NEEDLE", CAUSING IT TO ELONGATE. RESISTANCE WAS FELT UPON REMOVAL OF THE WIRE AND NO KINKING WAS NOTED. THE DEVICE WAS REMOVED AND A NEW SAME TYPE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 THE OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20090329 ↗MalfunctionJul 16, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
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 19751789 ↗MalfunctionJul 8, 2024Device Damaged Prior to Use; Material Split, Cut or Torn; Device Damaged Prior to Use; Material Split, Cut or Torn
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 19690854 ↗MalfunctionJul 8, 2024Device Damaged Prior to Use; Material Split, Cut or Torn; Device Damaged Prior to Use; Material Split, Cut or Torn
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 19690593 ↗InjuryJun 18, 2024Break; Stretched; Break; Stretched
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 19562538 ↗InjuryMay 21, 2024Break; Unraveled Material; Break; 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 19361585 ↗InjuryMay 11, 2023Break; Unraveled Material; Break; Unraveled Material
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 16916066 ↗MalfunctionMay 11, 2023Break; Break
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 16915517 ↗MalfunctionFeb 17, 2023Break; Detachment of Device or Device Component; Break; 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 Clinical Signs, Symptoms or Conditions
MAUDE report 16397450 ↗InjuryJul 22, 2022Break; Break
AS REPORTED, DURING A TRANSJUGULAR LIVER BIOPSY PROCEDURE, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S OUTER SHEATH SEPARATED UPON INSERTION OF THE DEVICE. ACCESS WAS OBTAINED IN THE INTERNAL JUGULAR VEIN AND THE ACCESS SITE WAS REPORTEDLY EXTREMELY SCARRED. ADVANCEMENT OF THE INTRODUCER WAS EXTREMELY DIFFICULT. THE RESISTANCE ENCOUNTERED NECESSITATED THE USE OF MULTIPLE COOK DILATORS, UP TO 8 FRENCH, TO DILATE THE ACCESS SITE. THE OUTER CANNULA/SHEATH SEPARATED AND SUBSEQUENTLY MIGRATED TO THE RIGHT SIDE OF THE PATIENT'S HEART. THE USER ATTEMPTED TO RETRIEVE THE SEPARATED PORTION OF THE DEVICE TWO TIMES WITH A SNARE; HOWEVER, THIS WAS UNSUCCESSFUL, AND THE DISTAL PIECE OF THE DEVICE REMAINS LODGED IN THE HEART. THE PATIENT IS REPORTEDLY ASYMPTOMATIC. THERE HAVE BEEN NO ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 15085442 ↗MalfunctionSep 30, 2021Entrapment of Device; Material Split, Cut or Torn
WHILE TRYING TO ACCESS FEMORAL ARTERY FOR CARDIAC CATH, TIP OF WIRE FROM MICROPUNCTURE KIT SHEARED OFF INTO SUBCUTANEOUS TISSUE, PHYSICIAN PRESENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 12553719 ↗MalfunctionApr 19, 2021Unraveled Material; Unraveled Material
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11686337 ↗MalfunctionMar 12, 2021Material Separation; Material Separation
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 11476285 ↗MalfunctionFeb 22, 2021Fracture; Unraveled Material; Fracture; Unraveled Material
ADDITIONAL INFORMATION WAS RECEIVED 01MAR2021. THE PHYSICIAN WAS ACCESSING A FISTULA WITH THE COMPLAINT DEVICE, REPORTEDLY VIA FEMORAL ACCESS. IT IS UNKNOWN IF THE MICRO WIRE WAS MANIPULATED OR REMOVED THROUGH THE NEEDLE.
Patient problems: No Information
MAUDE report 11358407 ↗MalfunctionFeb 18, 2021Loose or Intermittent Connection
WE OPENED A MICROPUNCTURE INTRODUCER SET AND THE INTRODUCER DOES NOT SCREW IN PROPERLY AND FASTEN. NO HARM WAS DONE TO THE PATIENT, ANOTHER KIT WAS OPENED UP, THE LOT NUMBER OF THE INTRODUCER MICROPUNCTURE SETS WERE PULLED FROM THE SHELF. MICROPUNCTURE INTRODUCER SET SAVED WITH PACKAGING.
Patient problems: Insufficient Information
MAUDE report 11342570 ↗MalfunctionFeb 2, 2021Stretched; Material Deformation; Stretched; Material Deformation
INFORMATION WAS AVAILABLE AND INADVERTENTLY OMITTED FROM THE INITIAL REPORT. THE FEMORAL ACCESS SITE WAS SCARRED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11267545 ↗MalfunctionJan 28, 2021Material Separation; Material Separation
UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE OUTER CATHETER WAS STRETCHED. THE DILATOR WAS NOT RETURNED. THE ANATOMY WAS NOTED TO BE SCARRED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11243049 ↗
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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.
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