MicropunctureRecalls & reported problems across all models
Cook Incorporated · 39 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 557
- Deaths reported
- 1
- Injuries reported
- 193
- Recalls
- 0
We found 39 models of Micropuncture by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 557 adverse event reports in the FDA's MAUDE database, received between Jul 11, 2014 and Sep 24, 2026 — classified as 1 death, 193 injuries, 363 malfunctions.
The most frequently reported specific device problem is “Material Separation” (183 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Micropuncture problems
Device problems
- Material Separation183
- Unraveled Material107
- Break86
- Stretched35
- Detachment of Device or Device Component34
- Material Frayed32
- Material Split, Cut or Torn26
- Kinked16
Patient problems
- No Clinical Signs, Symptoms or Conditions159
- No Known Impact Or Consequence To Patient116
- No Consequences Or Impact To Patient78
- Foreign Body In Patient77
- No Code Available72
- Device Embedded In Tissue or Plaque38
- No Patient Involvement27
- Insufficient Information20
Micropuncture models
39 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Micropuncture G47944INTRODUCER, CATHETER78 reports
- Micropuncture G48003INTRODUCER, CATHETER78 reports
- Micropuncture G48004INTRODUCER, CATHETER52 reports
- Micropuncture G48002INTRODUCER, CATHETER42 reports
- Micropuncture G47942INTRODUCER, CATHETER36 reports
- Micropuncture G36333INTRODUCER, CATHETER34 reports
- Micropuncture G43870INTRODUCER, CATHETER1 death25 reports
- Micropuncture G47940INTRODUCER, CATHETER22 reports
- Micropuncture G35550INTRODUCER, CATHETER21 reports
- Micropuncture G02972INTRODUCER, CATHETER19 reports
- Micropuncture G48007INTRODUCER, CATHETER19 reports
- Micropuncture G48008INTRODUCER, CATHETER17 reports
- Micropuncture G48006INTRODUCER, CATHETER16 reports
- Micropuncture G56201INTRODUCER, CATHETER16 reports
- Micropuncture G47950INTRODUCER, CATHETER13 reports
- Micropuncture G43871INTRODUCER, CATHETER10 reports
- Micropuncture G47949INTRODUCER, CATHETER9 reports
- Micropuncture G43872INTRODUCER, CATHETER8 reports
- Micropuncture G35551INTRODUCER, CATHETER5 reports
- Micropuncture G56202INTRODUCER, CATHETER5 reports
- Micropuncture G07410INTRODUCER, CATHETER4 reports
- Micropuncture G43869INTRODUCER, CATHETER4 reports
- Micropuncture G47708INTRODUCER, CATHETER3 reports
- Micropuncture G47945INTRODUCER, CATHETER3 reports
- Micropuncture G47709INTRODUCER, CATHETER2 reports
- Micropuncture G47710INTRODUCER, CATHETER2 reports
- Micropuncture G47947INTRODUCER, CATHETER2 reports
- Micropuncture G02988INTRODUCER, CATHETER1 report
- Micropuncture G13117INTRODUCER, CATHETER1 report
- Micropuncture G47946INTRODUCER, CATHETER1 report
- Micropuncture G47948INTRODUCER, CATHETER1 report
- Micropuncture G47952INTRODUCER, CATHETER1 report
- Micropuncture G48005INTRODUCER, CATHETER1 report
- Micropuncture G48009INTRODUCER, CATHETER1 report
- Micropuncture G49471INTRODUCER, CATHETER1 report
- Micropuncture G49472INTRODUCER, CATHETER1 report
- Micropuncture G49473INTRODUCER, CATHETER1 report
- Micropuncture G49474INTRODUCER, CATHETER1 report
- Micropuncture G53575DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
Recent Micropuncture adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Unraveled Material
As reported, during an unknown procedure, a MICROPUNCTURE TRANSITIONLESS ACCESS SET¿S wire unraveled while pulling the device out of 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.Additional information has been requested but is not available at this time.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881981 ↗InjurySep 9, 2026Material Separation
Patient problems: Foreign Body In Patient
MAUDE report 50698280 ↗MalfunctionSep 9, 2026Unraveled Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50697254 ↗MalfunctionAug 11, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50210714 ↗MalfunctionJul 30, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50084588 ↗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 ↗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 ↗MalfunctionNov 25, 2025Break; 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 23643648 ↗MalfunctionNov 24, 2025Contamination; Contamination
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 23631317 ↗InjuryNov 17, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED ON 02DEC2025. PER THE REPORTER, THE PROCEDURE WAS PERFORMED IN A PATIENT ROOM BY AN INTERNIST. THE SEPARATED PORTION OF THE DEVICE WAS REMOVED IN THE INTERVENTIONAL RADIOLOGY (IR) DEPARTMENT. NO ADDITIONAL ADVERSE EFFECTS HAVE BEEN REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 23573289 ↗MalfunctionNov 12, 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 23534455 ↗InjuryOct 27, 2025Break; 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 23392631 ↗MalfunctionOct 27, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in 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 23391865 ↗MalfunctionOct 27, 2025Contamination; Contamination
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 23391815 ↗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 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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