Mini Stick MAX H965457510Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15051684022941), received between Jul 9, 2026 and Jul 9, 2026 — classified as 1 malfunction.

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

14 other recalls cover devices cleared under the same FDA submission (K132713); 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. Jan 30, 2024Open, Classified

   Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case

   Z-1336-2024 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionJul 9, 2026

  ON [REDACTED], THE PHYSICIAN WAS PERFORMING RIGHT INTERNAL JUGULAR VENOUS ACCESS FOR A RIGHT HEART CATHETERIZATION UNDER ULTRASOUND GUIDANCE. ACCORDING TO THE MEDICAL RECORD, ON THE SECOND ATTEMPT TO ACCESS, THE WIRE ENTERED A DISSECTION PLANE JUST PAST THE NEEDLE TIP AND WAS UNABLE TO BE REMOVED FROM THE SOFT TISSUE. THE WIRE DID NOT APPEAR TO BE IN THE VESSEL BASED ON FLUOROSCOPY. THE PHYSICIAN ATTEMPTED TO MANEUVER THE WIRE OUT OF THE SOFT TISSUE WITHOUT SUCCESS. THE WIRE TIP BROKE DURING MANIPULATION AND WAS RETAINED IN THE SOFT TISSUE. THE RETAINED FOREIGN OBJECT REMAINED IN PLACE UNTIL [REDACTED]-4 DAYS LATER- WHEN IT WAS SUCCESSFULLY REMOVED FROM THE TISSUE SURROUNDING THE RIGHT INTERNAL JUGULAR VEIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 25763010 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132713. One submission often covers many models, so check the product and lot details in each record.

• Z-1340-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-758
• Z-1345-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-774
• Z-1339-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
• Z-1346-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-775
• Z-1337-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-752
• Z-1347-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-776
• Z-1342-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-762
• Z-1341-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-759
• Z-1348-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781
• Z-1343-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-765
• Z-1334-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-749
• Z-1335-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-750
• Z-1338-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-754
• Z-1344-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-767