CentroVena One 1MC0R7320Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741234729), received between Mar 12, 2026 and Aug 25, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Product Quality Problem

  It was reported by the clinician the guidewire felt flimsy during advancement. Issue resolved through withdrawal and re advancement of the guidewire. Procedure completed successfully. The guidewire did not bend, unravel fracture or sustain any damages during use, and was not replaced. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50436572 ↗
• MalfunctionJul 9, 2026Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT THEY HAD A VERY HARD TIME PULLING BACK ON THE NEEDLE TO SAFETY AND REMOVE. DURING THE INSERTION OF A CV1. THE INSERTING CLINICIAN HAD A VERY HARD TIME PULLING BACK ON THE NEEDLE TO SAFETY AND REMOVE. THIS CS NOTED THAT THE BLACK CLIPS HAD BEEN ROTATED SLIGHTLY DURING THE NEEDLE REMOVAL PROCESS. WHEN THE CLIPS AND WHITE HOUSING WERE RE-ALIGNED THE INSERTING CLINICIAN WAS ABLE TO REMOVE AND SAFETY BUT WITH WHAT APPEARED TO BE FORCE. AFTER REALIGNMENT CV1 WAS SUCCESSFULLY PLACED. IT APPEARS THAT THE TURNING OF THE CLIPS FORCES THE GUIDEWIRE TO THE SIDE AND STARTS TO RIP THE CATHETER SHEATH HOLDING THE NEEDLE AND GUIDEWIRE TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25764179 ↗
• MalfunctionJul 9, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25763744 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED NEEDLE STICK WHEN PLACING SUTURES. CLINICIAN WAS SENT FOR FOLLOW UP ACCORDING TO THEIR POLICY. PATIENT DID NOT HAVE ANY BLOOD BORNE DISEASES, AND NO ADVERSE EVENT OR SERIOUS INJURY TO PATIENT OR HEALTHCARE PROVIDER.

  Patient problems: Needle Stick/Puncture

  MAUDE report 25104154 ↗
• MalfunctionMar 25, 2026Material Deformation

  IT WAS FOUND DURING A SAMPLE INVESTIGATION THAT THE NEEDLE TIP APPEARED DAMAGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24688277 ↗
• MalfunctionMar 12, 2026Material Deformation

  IT WAS REPORTED, PATIENT WOULDN¿T LAY FLAT- PROPPED UP DUE TO CONDITION. THEY TRIED AXILLARY SUBCLAVIAN- IJ NOT AVAILABLE DUE TO TUBING ETC COULDN¿T ACCESS. HE WAS HAVING TROUBLE GETTING NEEDLE THROUGH VEIN- COULD SEE THE VEIN AND ARTERY ON ULTRASOUND BUT NEEDLE WOULDN¿T PENETRATE THE VEIN. HE PULLED BACK AND TRIED TO REINSERT IN THE VEIN AND THEN HE REMOVED THE CATHETER COMPLETELY- WHEN HE PULLED IT BACK HE SAW THE BUR. HE TRIED TO THREAD THE GUIDEWIRE AND HE MET RESISTANCE. AFTER HE MET RESISTANCE HE PULLED THE GUIDEWIRE BACK, TRIED TO REPOSITION THE NEEDLE A LITTLE BIT. CLINICIAN INSERTED NEEDLE AND WAS HAVING ISSUES GETTING THROUGH TISSUE. PROCEEDED TO INSERT AND ENCOUNTERED ISSUES THREADING GUIDEWIRE. SECOND INSERTION WAS A BREEZE- DIDN¿T USE THE SAME PUNCTURE SITE BUT WAS NEAR. NO PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24583644 ↗