Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity
Boston Scientific is recalling 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) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling the TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration), UPN M00561412. The devices are intended for use in flexible endoscopes to retrieve foreign body objects, such as polyps and food boluses. The recall involves 740 units distributed nationwide in the United States and in Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and the Netherlands.
The recall was initiated because the sterility of the device may be compromised due to a lack of pouch seal integrity. The affected lot numbers are H13061101, H13062403, H13062404, and H13071301. The devices were manufactured by Horizons International Corp. in Costa Rica and distributed by Boston Scientific in Natick, Massachusetts.
Healthcare providers and facilities should check their inventory for the specific lot numbers listed above. If the devices are found, they should be removed from use and returned to Boston Scientific according to the company's instructions. Patients who have already had these devices used should contact their healthcare provider with any questions or concerns.
The recalled product
- Product
- TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number (UPN):M00561412. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica Intended to be used in flexible endoscopes as a retrieval d
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 740
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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