FDA Class II Medical Devices

Maquet Cardiopulmonary Gmbh: Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);

Maquet Cardiopulmonary Gmbh · Affected quantity: 185617 units (5926 US, 179691 OUS)

Hazard
The packaging may not consistently maintain sterile barrier integrity.

Details
Distribution: 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;. Recall #Z-3145-2026, initiated 20260731. Voluntary: Firm initiated.

Products affected
Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);

Recall status
Ongoing

Reference: FDA Z-3145-2026 · Issued September 23, 2026 · Class II · Indexed by RecallSweep from the official FDA feed.

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