NA PIK dilator set largeRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 31, 2026Open, Classified

   The packaging may not consistently maintain sterile barrier integrity.

   Z-3146-2026 · Root cause: Packaging · FDA record ↗

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-3145-2026 · Jul 31, 2026 · Open, Classified
  Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
• Z-3144-2026 · Jul 31, 2026 · Open, Classified
  Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);