Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Issues
Boston Scientific is recalling TWISTER PLUS 26mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by compromised sterility of a medical device) fall under the 'Severe' category (Score 4).
Plain-English summary
Boston Scientific Corporation is recalling 620 units of the TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration). The devices are intended for use in flexible endoscopes to retrieve 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) M00561421 and include lot numbers H13061102, H13061103, H13061104, H13062401, and H13082603. The devices were distributed worldwide, including nationwide in the United States and in Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and the Netherlands.
Healthcare facilities and distributors should stop using the affected devices and contact Boston Scientific for further instructions. The agency has classified this as a Class II recall.
The recalled product
- Product
- TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):M00561421. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica. Intended to be used in flexible endoscopes as a retrieval
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 620
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 (5)
- Lot Numbers: H13061102
- H13061103
- H13061104
- H13062401
- 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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