Centurion ART945 (UDI 10653160366843)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653160366843), received between Mar 17, 2026 and Mar 17, 2026 — classified as 1 malfunction.

47 other recalls cover devices cleared under the same FDA submission (K213481); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026

  DURING INSERTION OF THE FEMORAL ART LINE THE GUIDEWIRE BEGAN TO UNRAVEL AND BECAME STUCK IN THE NEEDLE AND VESSEL. GUIDEWIRE WAS WITHDRAWN. SURGEON CALLED TO BEDSIDE TO DO A CUTDOWN TO RETRIEVE THE WIRE. INCISION NEEDED TO REMOVE THE GUIDEWIRE FROM THE ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616159 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K213481. One submission often covers many models, so check the product and lot details in each record.

• Z-3229-2026 · Aug 10, 2026 · Open, Classified
  Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.
• Z-3267-2026 · Aug 10, 2026 · Open, Classified
  Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q; 3) SLUH CRANIOTOMY PACK-LF, Catalog Number:
• Z-3209-2026 · Jul 31, 2026 · Open, Classified
  Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
• Z-3137-2026 · Jul 23, 2026 · Open, Classified
  Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
• Z-3070-2026 · Jul 20, 2026 · Open, Classified
  Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A DRAWER
• Z-3024-2026 · Jul 10, 2026 · Open, Classified
  Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ
• Z-2995-2026 · Jul 8, 2026 · Open, Classified
  Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU
• Z-3054-2026 · Jun 12, 2026 · Open, Classified
  Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Number: DYNDH1983A; 3) PEDI EMERGENCY TRAY-PURPLE, Catalog Numb
• Z-2736-2026 · Jun 10, 2026 · Open, Classified
  Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
• Z-2764-2026 · Jun 8, 2026 · Open, Classified
  MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
• Z-2748-2026 · Jun 5, 2026 · Open, Classified
  MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits
• Z-2747-2026 · Jun 5, 2026 · Open, Classified
  MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
• Z-2749-2026 · Jun 5, 2026 · Open, Classified
  MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOTAL KNEE BASIC, Medline Kit SKU DYNJ902378J; 3) TOTAL HIP, Medline Kit SKU DYNJ903492K;
• Z-2611-2026 · May 28, 2026 · Open, Classified
  Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M
• Z-2697-2026 · May 28, 2026 · Open, Classified
  Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PACK, Model Number: DYNJ88569A; 3) OPEN HEART PEDS PACK, Model Number: DYNJ88569B;

…and 32 more.