FDA-Device2026-09-23Class IIPACKAGING DEFECT
Maquet Cardiopulmonary Percutaneous Insertion Kit recalled for compromised sterile packaging
What this means
Maquet Cardiopulmonary identified that packaging on certain lots of their Percutaneous Insertion Kit (PIK) Guidewire 100 cm may not reliably maintain sterile barrier integrity. This medical device is used in cardiopulmonary procedures. The issue affects approximately 1,765 units in the U.S. and 66,606 units internationally across multiple countries.
- Check if your facility has any affected lot numbers listed in the recall notice.
- Contact Maquet Cardiopulmonary or your distributor for guidance on affected units.
- Do not use kits from the recalled lots if sterile barrier integrity cannot be confirmed.
- Report any adverse events or injuries to the FDA MedWatch program.
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
68371 units (1765 US, 66606 OUS)
Manufactured in
Kehler Str. 31, N/A, Rastatt, N/A, Germany
Products
Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3144-2026Want us to check the next one for you?
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