MEDLINE PICC0020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10653160364733), received between Apr 16, 2024 and Sep 30, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

46 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. May 21, 2026Open, Classified

   The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

   Z-2541-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break; Difficult or Delayed Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950998 ↗
• InjuryJul 15, 2025Migration; Migration

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 WHEN REMOVING THE PICC LINE THAT WAS PLACED ON (B)(6) 2025 BECAUSE "THE CATHETER TIP MIGRATED INTO THE AZYGOUS VEIN AND BECAME HARD TO FLUSH AND UNABLE TO ASPIRATE A BLOOD RETURN" THE CATHETER WAS "VERY COILED" UPON REMOVAL.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22506961 ↗
• InjuryApr 16, 2024Connection Problem; Connection Problem

  LEAKING AT THE HUB.

  Patient problems: Insufficient Information

  MAUDE report 19121062 ↗

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-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-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-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 31 more.