CX Preconnect pump inflation and deflation performance issues
Boston Scientific is recalling certain CX Preconnect pumps due to potential inflation and deflation performance issues that could affect their operation.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard involves potential operational failure of a safety-critical medical device, making it a risk-of-harm product where injury has not yet been reported, which corresponds to Score 3 (High) per the rubric.
Plain-English summary
Boston Scientific Corporation is recalling certain CX Preconnect with TENACIO Pump devices. The affected devices are identified by UPN 72404486 (15CM IP) and UPN 72404488 (21CM IP), with affected lot numbers including 1100676851, 1100676852, and 1100717673. These devices have been distributed worldwide, including in the United States and Canada.
The recalled devices may experience inflation and/or deflation performance issues. These performance issues could interfere with the intended operation of the device.
Healthcare providers and patients currently using affected devices should contact Boston Scientific Corporation to verify whether their device is subject to this recall and to discuss appropriate next steps.
The recalled product
- Product
- CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Pump Device
- Hazard
- inflation-deflation-failure
- pump-malfunction
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 (7)
- 1. UPN: 72404486 (15CM IP)
- UDI-DI: 00191506021658
- Lot numbers: 1100676851
- 1100676852
- 2. UPN: 72404488 (21CM IP)
- UDI-DI: 00191506021672
- Lot numbers: 1100717673
Distribution
Distributed nationwide across the United States.
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