Boston Scientific Recalls Twister Plus Retrieval Devices Due to Seal Integrity Issues
Boston Scientific is recalling 253 Twister Plus 26mm 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) without reported illnesses or injuries, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Boston Scientific Corporation is recalling 253 units of the Twister Plus 26mm Rotatable Retrieval Device (UPN: M00561420). The device is intended for use in flexible endoscopes to retrieve foreign body objects, such as polyps and food boluses. The recall is due to a lack of pouch seal integrity, which may compromise the sterility of the device.
The affected units were distributed worldwide, including the United States (nationwide), Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and the Netherlands. The specific lot numbers involved are H13061102, H13061103, H13061104, H13062401, H13062402, H13071302, and H13082603.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. Boston Scientific is the recalling firm, and the devices were manufactured by Horizons International Corp. in Costa Rica.
The recalled product
- Product
- TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):M00561420. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica Intended to be used in flexible endoscopes as a retrieva
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 253
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)
- Lot Numbers: H13061102
- H13061103
- H13061104
- H13062401
- H13062402
- H13071302
- H13082603
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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