Boston Scientific is recalling 1 CX Preconnect with TENACIO Pump sold to healthcare providers worldwide, including the US and Canada. The device may experience inflation and/or deflation performance issues. Healthcare providers and patients should stop using the device and follow manufacturer recall instructions.
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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This device is a CX Preconnect with TENACIO Pump used in clinical settings to assist device inflation. It was distributed worldwide to healthcare providers, including the US and Canada.
The device may fail to inflate or deflate correctly, potentially impacting procedure outcomes or device effectiveness.
This recall is not described as part of a broader industry pattern in the provided notice.
The recall may cause procedural delays or require device replacement to maintain treatment efficacy.
Official recall details are on the FDA recall page linked in the notice and the manufacturer communications.
Remedy processes for medical device recalls vary; follow manufacturer guidance and FDA notices. Expect processing steps to take weeks.
Retain all recall notices, labeling, and correspondence. Photograph device labels showing UPN, UDI-DI, and lot numbers.
UPN 72404486 (15CM IP) UDI-DI 00191506021658; Lot numbers 1100676851, 1100676852. UPN 72404488 (21CM IP) UDI-DI 00191506021672; Lot number 1100717673. Worldwide distribution to healthcare providers, including the United States and Canada. Recall date 2025-09-11.
No injuries or incidents have been reported.
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