ClosureFast MPK-4FRecalls & reported problems
Covidien LP · Micro Puncture Kit · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521140370), received between Oct 2, 2023 and Oct 2, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 2, 2023Break; Break
A PHYSICIAN WAS ATTEMPTING TO USE A MICRO INTRODUCER SHEATH FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV). THE IFU WAS FOLLOWED. IT WAS REPORTED WHILE ACCESSING THE VEIN, THE PHYSICIAN NOTICED THAT THE WIRE TIP WAS ALREADY PRE BENT. THE PHYSICIAN DECIDED TO ACCESS AND BELIEVES THAT THE BENT WIRE TIP GRABBED ONTO A VEIN VALVE AND BROKE OFF INTO THE PATIENT. IT WAS DECIDED TO GO FORWARD WITH THE ABLATION TO GO AHEAD A CLOSE OFF THE VEIN, THAT WAY THE PIECE OF THE WIRE COULD NOT TRAVEL INTO THE DEEP VENOUS SYSTEM. ABLATION WAS COMPLETE SUCCESSFULLY AND PATIENT WAS SCHEDULED WITH VASCULAR SURGERY TO HAVE WIRE TIP REMOVED. THAT PROCEDURE WAS DONE SUCCESSFULLY AND NO PATIENT INJURY WAS REPORTED. PHYSICIAN IS NOT COMFORTABLE USING SHEATHS FROM THAT LOT NUMBER AND IS REQUESTING ALL 75 BE REPLACED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 17858242 ↗
Other Percutaneous sheath introducer kit devices
- Transcarotid/Peripheral Access Kit KIT-075-03Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall12 reports
- Transitionless Stiffen Micro-Introducer Kit KIT-039-03Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall2 reports
- Micro-Introducer Kit KIT-002-28Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall2 reports
- Stiffen Micro-Introducer Kit KIT-011-62Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall1 report
- Transitionless Micro-Introducer Kit KIT-038-04Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall1 report
- Posi-Stick® Introducer Kit KIT-081-02Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall0 reports
- Micro-Introducer Kit KIT-002-34Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall0 reports
- Pediatric Tearaway Introducer Kit KIT-051-01Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall0 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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