Transcarotid/Peripheral Access Kit KIT-075-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00841268107250), received between Mar 16, 2021 and Sep 23, 2026 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (10 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Jun 26, 2026Class IIOpen, Classified

   Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.

   Z-2917-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Material Integrity Problem

  MPK pad print issues occurred.

  Patient problems: Embolism/Embolus

  MAUDE report 50869639 ↗
• MalfunctionSep 18, 2026Material Integrity Problem

  Patient problems: Insufficient Information

  MAUDE report 50828648 ↗
• InjuryAug 7, 2026Material Integrity Problem

  The device either was manufactured missing all of the markings or it did not have them at all during manufacturing phase.

  Patient problems: Embolism/Embolus

  MAUDE report 50181855 ↗
• InjuryAug 7, 2026Material Integrity Problem

  The 4fr micro puncture sheath was inserted per protocol. The rest of the procedure proceeded like normal until the flow controller was disconnected and the filter was assessed. There was a small strip of black material noted in the filter. Upon further assessment, it was noted that one of the black markers from the 4fr sheath was missing. After conversing with the doctor, the conclusion was made that the black strip in the filter was probably from the 4fr micro sheath.

  Patient problems: Embolism/Embolus

  MAUDE report 50181556 ↗
• MalfunctionAug 6, 2026Material Integrity Problem

  Patient problems: Embolism/Embolus

  MAUDE report 50160616 ↗
• MalfunctionAug 6, 2026Material Integrity Problem

  Patient problems: Embolism/Embolus

  MAUDE report 50160399 ↗
• MalfunctionAug 6, 2026Material Integrity Problem

  Patient problems: Embolism/Embolus

  MAUDE report 50159838 ↗
• MalfunctionJun 30, 2026Material Integrity Problem

  LETTERS ALL GONE, STARTED TO INSERT IT NOT KNOWING WHERE THE 2 1/2 WAS. THEY DROPPED THE ORIGINAL SO THEY OPENED A NEW ONE AND I COULD SEE IT UNTIL IT WAS IN TOO DEEP.

  Patient problems: Embolism/Embolus

  MAUDE report 25668177 ↗
• MalfunctionJun 30, 2026Material Integrity Problem

  AS SURGEON WAS INSERTING THE SHEATH INTO THE RIGHT CAROTID ARTERY, SHE NOTED THE BLACK DEPTH MARKINGS WERE COMING OFF. NEW MICROPUNCTURE KIT OPENED AND NEW SHEATH USED WITHOUT ISSUE. UPON COMPLETION OF PROCEDURE, BLACK DEPTH MARKINGS WERE FOUND IN THE NEUROPROTECTION SYSTEM FILTER.

  Patient problems: Embolism/Embolus

  MAUDE report 25666224 ↗
• MalfunctionMay 28, 2025Material Integrity Problem; Material Integrity Problem

  TIP OF WIRE OF TRANSAORTIC/PERIPHERAL ACCESS KIT BROKE OFF IN CAROTID ARTERY REQUIRING EXPLORATION TO RETRIEVE AND SUTURE REPAIR OF CAROTID ARTERY. ENTRY NEEDLE BEVEL SHORTER THAN USUAL AND WIRE WAS DIFFICULT TO MOVE THROUGH NEEDLE TIP.

  Patient problems: Insufficient Information

  MAUDE report 22099884 ↗
• InjuryDec 6, 2021Material Frayed; Physical Resistance/Sticking

  AS RECEIVED FROM THE CUSTOMER (IT WAS REPORTED BY END USER THAT ON (B)(6) 2021, DURING A TCAR PROCEDURE, MICROWARE WAS ADVANCED THROUGH NEEDLE ONLY A COUPLE OF INCHES. MICRODILATOR WAS THEN USED. WHEN REMOVING DILATOR AND WIRE, WIRE WOULD NOT COME BACK. WIRE WAS STUCK AND FLOPPY TIP WAS FRAYED AND WAS STUCK IN PATIENT. PHYSICIAN HAD TO OPEN ARTERY TO REMOVE WIRE. PATIENT STATUS IS STABLE).

  Patient problems: Foreign Body In Patient

  MAUDE report 12940648 ↗
• MalfunctionMar 16, 2021Material Separation; Physical Resistance/Sticking

  END USER SENT COMPLAINT DESCRIPTION TO DISTRIBUTER ((B)(4)) AND THE DISTRIBUTER NOTIFIED MANUFACTURER (GALT) AS STATED. (IT WAS REPORTED THAT DURING A TCAR PROCEDURE, THE MICRO-PUNCTURE SHEATH CAME APART IN HALF WHEN REMOVING AFTER TUNNEL. BOTH PIECES WERE RETRIEVED AND NO HARM TO PATIENT. SILK ROAD FOLLOWED UP AND GOT THE FOLLOWING ADDITIONAL INFORMATION: DURING THE PROCEDURE THE PHYSICIAN WAS TUNNELING THE SHEATH DUE TO A DEEP CAROTID. PHYSICIAN TUNNELED, .035 WIRE WAS ADVANCED INTO THE ECA AND THEN DURING THE PROCESS OF EXCHANGING THE MICRO-PUNCTURE SHEATH FOR THE 8FR SHEATH THE PHYSICIAN NOTICED RESISTANCE. SHE PULLED STEADY BACK TENSION ON THE MICRO-PUNCTURE SHEATH AND WHEN IT CAME OUT, WE NOTICED THE ENTIRE SHEATH WAS NOT INTACT. THE PHYSICIAN THEN SAW THE REST OF THE SHEATH IN THE CCA THROUGH HER CUTDOWN AND REMOVED THE REST SURGICALLY. THE REST OF THE TCAR WENT WELL AND PATIENT IS DOING WELL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11497521 ↗