Imager II 5F Angiographic Catheters, 5 units per package.
Reported: April 1, 2020 Initiated: February 11, 2020 #Z-1555-2020
Product Description
Imager II 5F Angiographic Catheters, 5 units per package.
Reason for Recall
Potential for tip detachment of Imager II 5F Angiographic Catheters
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 1068827 Single Units
- Distribution
- Worldwide distribution. US nationwide, Australia, Belgium, Brazil, Canada, Switzerland, China, Colombia, Cyprus, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Indonesia, Israel, India, Italy, Jordan, Japan, South Korea, Lebanon, Lithuania, Mexico, Malaysia, Netherlands, Norway, Poland, Russia, Sweden, Slovakia, Turkey, Taiwan, and South Africa.
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
Imager II 5F Angiographic Catheters, 5 units per package.. Recalled by Boston Scientific Corporation. Units affected: 1068827 Single Units.
Why was this product recalled? ▼
Potential for tip detachment of Imager II 5F Angiographic Catheters
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 1, 2020. Severity: Critical. Recall number: Z-1555-2020.
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