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U.S. Department of Health and Human Services

Class 2 Device Recall Captivator/Captiflex/Sensation Short Throw SingleUse Polypectomy Snares

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 Class 2 Device Recall Captivator/Captiflex/Sensation Short Throw SingleUse Polypectomy Snaressee related information
Date Initiated by FirmJanuary 19, 2021
Create DateMarch 04, 2021
Recall Status1 Open3, Classified
Recall NumberZ-1170-2021
Recall Event ID 87221
510(K)NumberK131700 
Product Classification Snare, flexible - Product Code FDI
ProductCaptivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M00560321 (Box 5), M00560320; M00562651 (Box 5), M00562650; M00562652 (Box 20), M00562650; M00562671 (Box 5), M00562670; M00562672 (Box 20), M00562670; M00562673 (Box 40), M00562670; M00562691 (Box 5); M00562690; M00562692 (Box 20), M00562690; M00562693 (Box 40), M00562690.
Code Information Outer box GTIN: 08714729283904 Inner pouch GTIN: 08714729747598 Lot/Batch#: 24818278, 24906823, 25042455  Outer box GTIN: 08714729283928 Inner pouch GTIN: 08714729747611 Lot/Batch#: 24685766, 24817145, 24899710, 24739786, 25006735, 24861901  Outer box GTIN: 08714729158110 Inner pouch GTIN: 08714729748069 Lot/Batch#: 24685764, 24890051, 24824132  Outer box GTIN: 08714729268802 Inner pouch GTIN: 08714729748069 Lot/Batch#: 25023345  Outer box GTIN: 08714729158141 Inner pouch GTIN: 08714729748083 Lot/Batch#: 24699718, 24939626, 24861739  Outer box GTIN: 08714729268819 Inner pouch GTIN: 08714729748083 Lot/Batch#: 24824134, 25006729, 24709534  Outer box GTIN: 08714729501664 Inner pouch GTIN: 08714729748083 Lot/Batch#: 25023203, 24697822, 24739587, 24942292, 24909214, 24824136  Outer box GTIN: 08714729158158 Inner pouch GTIN: 08714729748106 Lot/Batch#: 24856636, 24927642, 24699218  Outer box GTIN: 08714729268826 Inner pouch GTIN: 08714729748106 Lot/Batch#: 24835709, 24818605, 25023343  Outer box GTIN: 08714729501671 Inner pouch GTIN: 08714729748106 Lot/Batch#: 24909216, 24758832, 24872119, 24994171, 25048397, 2475126, 24929431, 24995438        
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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