LGX preconnect pumps without InhibiZone recalled over inflation deflation issues
Boston Scientific is recalling LGX Preconnect with TENACIO Pump without InhibiZone because of the potential for inflation or deflation performance issues or difficulties.
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: Scored 3 under the risk-of-harm criterion: an implanted device that may not inflate or deflate as intended is a clinical risk, and no injuries are reported.
Plain-English summary
LGX Preconnect with TENACIO Pump without InhibiZone is being recalled, covering UPNs 72404405 (12CM IP) and 72404407 (18CM IP).
The recall concerns the potential for devices to experience inflation and/or deflation performance issues or difficulties.
The affected product includes lots 1100687060 and 1100687061 for UPN 72404405. The enforcement record lists the quantity as 0 units. Distribution was worldwide, including nationwide in the United States and to Canada. The FDA has classified the action as Class II.
The enforcement record describes the performance issue and reports no injuries. Facilities holding affected lot numbers should follow Boston Scientific's instructions.
The recalled product
- Product
- LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
- Manufacturer
- Boston Scientific Corporation
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 (8)
- 1. UPN: 72404405 (12CM IP)
- UDI-DI: 00191506021252
- Lot numbers: 1100687060
- 1100687061
- 2. UPN: 72404407 (18CM IP)
- UDI-DI: 00191506021276
- Lot numbers: 1100676894
- 1100676895
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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