Boston Scientific recalled 172 units of the CXR Preconnect with TENACIO Pump with InhibiZone worldwide. The recall was initiated on 2025-09-11 and remains active as of 2025-10-22. The devices can experience inflation and/or deflation performance issues. Healthcare providers should stop using the devices and follow manufacturer instructions for recall remediation.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter
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The CXR Preconnect with TENACIO Pump with InhibiZone is a medical device used in clinical settings. It combines a preconnect component with a TENACIO pump and an InhibiZone feature for protective purposes.
The device could experience inflation or deflation performance issues, potentially affecting pressure regulation or operation.
This recall is not described as part of a broader industry pattern in the provided data.
Impact is primarily clinical and logistical. Hospitals and patients may face device downtime and the need for remediation, with potential treatment delays.
Manufacturer recall notices and FDA enforcement page Z-0143-2026 provide identifiers like UPNs, LOT numbers, and UDI-DI.
Remediation timelines vary; contact Boston Scientific for specific timelines on refunds or replacements.
Keep recall notices, communications with healthcare providers, serials, LOts, and replacement confirmations.
Product: CXR Preconnect with TENACIO Pump with InhibiZone. UPNs include 72404461, 72404462, 72404463, 72404464, 72404465, 72404466, 72404467, 72404468, 72404469. Classification: Class II recall. Quantity: 172 units. Distribution: Worldwide, including US nationwide and Canada.
No injury counts or specific incident narratives are provided in the recall notice. The hazard level is listed as HIGH.
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