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FDA · Medical devices ·

Percutaneous Insertion Kit (PIK) recall

Maquet Cardiopulmonary Gmbh recalled Percutaneous Insertion Kit (PIK) on September 23, 2026 because of the packaging may not consistently maintain sterile barrier integrity. It was sold nationwide.

Why it was recalled

The packaging may not consistently maintain sterile barrier integrity.

What's recalled

Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);

Quantity: 68371 units (1765 US, 66606 OUS)

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Maquet Cardiopulmonary Gmbh, Rastatt, N/A
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, South…
Status
Ongoing
Recall number
Z-3144-2026
Source
U.S. Food and Drug Administration

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