Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity Issues
Boston Scientific is recalling 425 TWISTER PLUS 22mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.
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: The recall involves a medical device where sterility may be compromised, posing a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Boston Scientific Corporation is recalling 425 units of the TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration). The device is intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. The recall was initiated because the sterility of the device may be compromised due to a lack of pouch seal integrity.
The affected products are identified by Universal Product Number (UPN) M00561411 and specific lot numbers: H13061101, H13062403, H13062404, and H13071301. The devices were distributed worldwide, including in the United States (nationwide), Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and the Netherlands.
Healthcare facilities and consumers who have these specific devices should stop using them and contact Boston Scientific Corporation for further instructions on how to return or dispose of the product.
The recalled product
- Product
- TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign bod
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 425
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)
- Lot Numbers: H13061101
- H13062403
- H13062404
- H13071301
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 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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