NA PIK 150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04037691730677), received between Oct 24, 2025 and Oct 24, 2025 — classified as 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.

2 other recalls cover devices cleared under the same FDA submission (K131666); 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. Jul 31, 2026Open, Classified

   The packaging may not consistently maintain sterile barrier integrity.

   Z-3145-2026 · Root cause: Packaging · 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.

• MalfunctionOct 24, 2025Break; Break

  COMPLAINT#: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377820 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131666. One submission often covers many models, so check the product and lot details in each record.

• Z-3144-2026 · Jul 31, 2026 · Open, Classified
  Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
• Z-3146-2026 · Jul 31, 2026 · Open, Classified
  Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);