FDA-Device2026-09-23Class IIPACKAGING DEFECT
Maquet Cardiopulmonary Percutaneous Insertion Kit recalled for compromised sterile packaging
What this means
Maquet Cardiopulmonary has recalled specific lots of its Percutaneous Insertion Kit (PIK) Guidewire 150 cm because the packaging may not reliably maintain sterile barrier integrity. This could allow contamination of the sterile device. The company identified the issue and is recalling affected units.
- Check if you have a recalled lot number (see FDA notice for full list by model).
- Contact Maquet Cardiopulmonary or your facility's medical device supplier for instructions.
- Do not use units from affected lots without confirming with the manufacturer.
The agency's original wording
Hazard
The packaging may not consistently maintain sterile barrier integrity.
Intended for
Adults
Illnesses reported
None reported
Sold states
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 Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom;
Affected count
185617 units (5926 US, 179691 OUS)
Manufactured in
Kehler Str. 31, N/A, Rastatt, N/A, Germany
Products
Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3145-2026More Maquet recalls
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