Penumbra, Inc. — Class II: Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Penumbra, Inc. has initiated a Class II recall for the Penumbra System RED 68 Reperfusion Catheter (REF: RED68KIT) due to manufacturing issues that may lead to catheter fractures.
This affects Penumbra, Inc., healthcare facilities utilizing reperfusion catheters, and departments responsible for medical device procurement, quality control, and neuro-interventional procedures.
A product fracture in a reperfusion catheter represents a significant mechanical failure during clinical use. Because the source identifies 'manufacturing issues' as the root cause, this suggests a potential gap in production quality controls or material integrity verification that requires remediation to prevent recurrence.
QA and manufacturing teams should review current production and inspection records for this specific reference number (RED68KIT) to identify any deviations. Regulatory teams should monitor for updated field safety notices or specific lot-level information as this ongoing recall progresses.
Class II. Reason: Due to manufacturing issues, reperfusion catheters may fractures. Product: Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT. Firm: Penumbra, Inc. (Livermore CA United States). Status: Ongoing.
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