Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity
Boston Scientific is recalling 3,300 TWISTER PLUS 26mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, creating 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 3,300 units of the TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 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 is due to a potential lack of pouch seal integrity, which may compromise the sterility of the device.
The affected products are identified by Universal Product Number (UPN) M00561422 and specific lot numbers: H13061102, H13061104, H13062401, H13062402, H13071302, 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 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 10 configuration) Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. Universal Product Number (UPN):M00561422 Distributed by: Boston Scientific…
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 3,300
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 (6)
- Lot Numbers: H13061102
- 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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