Penumbra System RED 68 Reperfusion Catheter Recall Due to Fracture Risk
Penumbra, Inc. is recalling its RED 68 Reperfusion Catheter due to manufacturing issues that may cause the device to fracture during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a medical device with potential to fracture during use, posing risk of harm without reported injuries.
Plain-English summary
Penumbra, Inc. is recalling its Penumbra System RED 68 Reperfusion Catheter (REF: RED68KIT) due to manufacturing issues that may cause the catheter to fracture during use. The recall affects devices with UDI 00815948024113 and lots H00008699, H00008701, H00008702, H00008703, and C00020038.
The product was distributed worldwide, including throughout the United States and multiple international countries such as Brazil, Canada, Colombia, Ecuador, Indonesia, Israel, Lebanon, Mexico, Mongolia, Philippines, Saudi Arabia, Thailand, and the United Arab Emirates.
Healthcare providers and patients should return the affected catheters to Penumbra, Inc. for a replacement or refund. No injuries or illnesses have been reported in connection with this issue.
The recalled product
- Product
- Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
- Manufacturer
- Penumbra, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI: 00815948024113/Lots: H00008699
- H00008701
- H00008702
- H00008703
- and C00020038
Distribution
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