FDA-Device2026-09-23Class IIPACKAGING DEFECT
Maquet Cardiopulmonary Percutaneous Insertion Kit recalled for sterile barrier integrity failure
What this means
Maquet Cardiopulmonary's Percutaneous Insertion Kit (PIK) dilator set L may have packaging that does not reliably maintain sterile barrier integrity. This affects specific lot numbers distributed worldwide. No injuries have been reported.
- Check if you have the affected lot numbers listed in the recall notice
- Contact your supplier or Maquet Cardiopulmonary for instructions on device handling or replacement
- Do not use affected units if sterility cannot be verified
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
16697 units (492 USA, 16205 OUS)
Manufactured in
Kehler Str. 31, N/A, Rastatt, N/A, Germany
Products
Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3146-2026More Maquet recalls
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