Micropuncture G35550Recalls & 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
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00827002355507), received between Nov 7, 2017 and Jul 27, 2023 — classified as 9 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Material Separation” (12 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
Device problems
- Material Separation12
- Material Frayed4
- Break3
- Contamination /Decontamination Problem1
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient4
- No Clinical Signs, Symptoms or Conditions4
- No Patient Involvement4
- No Code Available3
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient3
- Device Embedded In Tissue or Plaque2
- Perforation of Vessels1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2023Break; 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; No Clinical Signs, Symptoms or Conditions
MAUDE report 17406291 ↗MalfunctionSep 8, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED, A HAIR WAS FOUND INSIDE THE SEALED, STERILE PACKAGE OF A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET. THE DEVICE HAD NOT YET BEEN DELIVERED TO THE USER FACILITY, AND THEREFORE, DID NOT MAKE CONTACT WITH ANY PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15381056 ↗InjuryMay 19, 2022Break; Break
AS REPORTED, UPON COMPLETION OF A FISTULAGRAM, THE OUTER CANNULA/SHEATH INCLUDED IN A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET SEPARATED IN THE PATIENT UPON REMOVAL OF THE DEVICE. THE ACCESS SITE WAS SCARRED AND CALCIFIED; HOWEVER, RESISTANCE WAS REPORTEDLY "NOTHING OUT OF THE ORDINARY". THE SEPARATED PORTION OF THE DEVICE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT WITH FORCEPS AND THE PATIENT WAS THEN CLOSED. UPON EXAMINATION OF THE DEVICE ON THE BACK TABLE, PART OF IT REPORTEDLY "FELL APART AGAIN". 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 HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 14434935 ↗InjuryAug 30, 2021Material Separation; Material Separation
NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SUBMITTED.
Patient problems: Perforation of Vessels
MAUDE report 12388229 ↗InjuryJun 24, 2021Material Separation; Material Separation
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 12057209 ↗InjuryMar 12, 2021Material Separation; Material Separation
ADDITIONAL INFORMATION WAS RECEIVED 30MAR2021. THE COMPLAINT DEVICE WAS INSERTED THROUGH A PREVIOUSLY PLACED CLOSURE DEVICE. RESISTANCE WAS NOT ENCOUNTERED. THE SEPARATED PORTION OF THE OUTER CANNULA WAS NOT ABLE TO BE RETRIEVED FROM THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 11472289 ↗MalfunctionJan 18, 2021Material Separation; Material Separation
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11188588 ↗MalfunctionNov 16, 2020Material Separation; Material Separation
AS REPORTED, THE OUTER PORTION OF A DILATOR IN A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET BROKEN OFF INSIDE THE PATIENT. THE DEVICE SEGMENT WAS RETRIEVED. NO ADVERSE EFFECTS HAVE BEEN REPORTED DUE TO THE ALLEGED MALFUNCTION. ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10843489 ↗InjuryOct 30, 2020Material Separation; Material Separation
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Code Available
MAUDE report 10762002 ↗InjurySep 30, 2019Material 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 Code Available
MAUDE report 9135390 ↗MalfunctionSep 4, 2019Detachment 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 8959374 ↗InjuryAug 28, 2019Break
MICRO PUNCTURE ACCESS OBTAINED IN RIGHT COMMON FEMORAL ARTERY. DURING SHEATH EXCHANGE AND REMOVAL OF MICRO PUNCTURE SHEATH, THE MICRO SHEATH SHEARED OFF ON THE RIGHT GROIN AREA. APPROXIMATELY 5 CM OF DISTAL PORTION OF MICRO INTRODUCER SHEATH SHEARED OFF IN BODY. FDA SAFETY REPORT ID # (B)(4).
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8944759 ↗MalfunctionJun 18, 2019Material Frayed; Material Frayed
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 8707907 ↗MalfunctionMay 15, 2019Material Frayed; Material Frayed
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 8613670 ↗InjuryNov 5, 2018Material Separation; Material Separation
ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. THIS INFORMATION IS DETAILED IN SECTION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8037048 ↗MalfunctionApr 5, 2018Material Separation; Material Separation
IT WAS REPORTED THAT DURING A LEFT LOWER EXTREMITY ANGIOGRAM WITH ARTERIOVENOUS FISTULA (AVF) EMBOLIZATION, THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET SEPARATED FROM THE HUB; THEREFORE, WAS NOT USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET. 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 7399352 ↗MalfunctionApr 4, 2018Material Frayed; Material Frayed
IT WAS REPORTED THAT AFTER OPENING THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET, THE TIP WAS FRAYED (MEDWATCH 1820334-2018-00904). A SECOND MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET WAS THEN OPENED WITH THE SAME RESULTS (MEDWATCH 1820334-2018-00905). NEITHER DEVICE WAS USED ON THE PATIENT. THE UNSPECIFIED PROCEDURE WAS SUCCESSFULLY COMPLETED USING A THIRD MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Patient Involvement
MAUDE report 7396775 ↗MalfunctionApr 4, 2018Material Frayed; Material Frayed
IT WAS REPORTED THAT AFTER OPENING THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET, THE TIP WAS FRAYED (MEDWATCH 1820334-2018-00905). A SECOND MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET WAS THEN OPENED WITH THE SAME RESULTS MEDWATCH (1820334-2018-00904). NEITHER DEVICE WAS USED ON THE PATIENT. THE UNSPECIFIED PROCEDURE WAS SUCCESSFULLY COMPLETED USING A THIRD MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Patient Involvement
MAUDE report 7396772 ↗InjuryApr 2, 2018Material Separation; Material Separation
IT WAS REPORTED THAT THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET SEPARATED INTO TWO PARTS DURING AN AXILLARY BI-FEMORAL BYPASS PROCEDURE. THE SHEATH AND DILATOR WERE INSERTED OVER THE WIRE INTO THE AXILLARY ACCESS SITE. REPORTEDLY, THIS SITE WAS NEITHER SIGNIFICANTLY SCARRED NOR CALCIFIED. THE MICROPUNCTURE WIRE AND DILATOR WERE REMOVED AND A SHORT BENSON WIRE WAS INSERTED. WHILE THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET WAS BEING REMOVED, IT SEPARATED INTO TWO PARTS. THE TWO PARTS WERE RETRIEVED OVER THE .035 GUIDEWIRE SHEATH USING FORCEPS. A SHORT SHEATH WAS PUT IN PLACE AND AN ANGIOPLASTY WAS SUCCESSFULLY COMPLETED RESULTING IN A SIGNIFICANT IMPROVEMENT IN PATENCY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AND, ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 7389346 ↗MalfunctionNov 15, 2017Material Separation; Material Separation
IT WAS REPORTED THAT DURING A FISTULA REPAIR PROCEDURE, THE MICROPUNCTURE TRANSITION-LESS STIFFENED CANNULA ACCESS SET INTRODUCER SHEATH FRACTURED AT THE SITE WHERE THE SHEATH MEETS THE HUB. THE INTRODUCER SHEATH BROKE AS THE PHYSICIAN WAS REMOVING IT FROM THE PATIENT. NO INTERVENTION WAS REQUIRED AS A RESULT. ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7033163 ↗MalfunctionNov 7, 2017Material Separation; Material Separation
IT WAS REPORTED THAT THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET INTRODUCER SHEATH FRACTURED AT THE SITE WHERE THE SHEATH MEETS THE HUB. THE INTRODUCER SHEATH BROKE AS THE PHYSICIAN WAS REMOVING IT FROM THE PATIENT. NO INTERVENTION WAS REQUIRED AS A RESULT. TWO MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SETS WERE UTILIZED DURING PROCEDURES, AND ONE WAS REPORTED TO BE UNOPENED/ UNUSED. ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7008008 ↗
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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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