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U.S. Department of Health and Human Services

Class 2 Device Recall Captivator II SingleUse Polypectomy Snares

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 Class 2 Device Recall Captivator II SingleUse Polypectomy Snaressee related information
Date Initiated by FirmJanuary 19, 2021
Create DateMarch 04, 2021
Recall Status1 Open3, Classified
Recall NumberZ-1169-2021
Recall Event ID 87221
510(K)NumberK133987 
Product Classification Snare, flexible - Product Code FDI
ProductCaptivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; M00561222 (Box 20), M00561220; M00561223 (Box 40), M00561220; M00561233 (Box 40), M00561230.
Code Information Outer box GTIN: 08714729855934 Inner pouch GTIN: 08714729861263 Lot/Batch#: 25053639  Outer box GTIN: 08714729855903 Inner pouch GTIN: 08714729861294 Lot/Batch#: 24948407, 24670592, 24679619, 24676929, 24939628  Outer box GTIN: 08714729861300 Inner pouch GTIN: 087147298 61294 Lot/Batch#: 24770325, 24952552, 24665104  Outer box GTIN: 08714729861317 Inner pouch GTIN: 08714729861294 Lot/Batch#: 24679614, 25054403  Outer box GTIN: 08714729861348 Inner pouch GTIN: 08714729861324 Lot/Batch#: 24772995
FEI Number 3005099803
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information ContactNicole Pshon
763-494-1133
Manufacturer Reason
for Recall		Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
FDA Determined
Cause 2		Process change control
ActionOn 01/21/2021, Boston Scientific issued Urgent Medical Device Product Removal notices to customers via e-mail. The removal notice is due to an incomplete seal of the inner pouch which could result in a sterile barrier breach rendering the specified lots of polypectomy snare devices non-sterile.
Quantity in Commerce335,788 units total (Domestic: 222,882, Foreign: 112,906)
DistributionUS nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FDI
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