TENACIO pumps without InhibiZone recalled over inflation and deflation issues
Boston Scientific is recalling TENACIO Pump without InhibiZone, UPN 72404420, 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
TENACIO Pump without InhibiZone, UPN 72404420, is being recalled.
The recall concerns the potential for devices to experience inflation and/or deflation performance issues or difficulties.
The affected product covers lots 1100720566, 1100720567 and 1100720568. 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
- TENACIO Pump without InhibiZone; UPN: 72404420;
- 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 (4)
- UPN: 72404420
- UDI-DI: Lot numbers: 1100720566
- 1100720567
- 1100720568
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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