Z-1170-2021Class II

Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN...

Name: Z-1170-2021 Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN...
Creator: Boston Scientific Corporation
Published: 2021-01-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2021-01-19 / Open, Classified / root cause: packaging

FDA source

Boston Scientific Corporation began a recall of Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M00560321 (Box 5)... on 2021-01-19. FDA classified it as Class II and gives the reason as "Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1170-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-01-19
Posted: 2021-03-04
Recalling firm: Boston Scientific Corporation
Product: Captivator/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.
Product code: FDI Snare, Flexible
Reason for recall: Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
Root cause tag: packaging
FDA root cause: Process change control
Action: On 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 commerce: 335,788 units total (Domestic: 222,882, Foreign: 112,906)
Distribution: US nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1170-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1168-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-10	2021-03-04
Z-1169-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-10	2021-03-04
Z-1170-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-10	2021-03-04

Product code FDI

K131700Class IISensation Short Throw, Captiflex, Captivator, Captivator II, Profile, Single-Use Polypectomy SnaresBoston Scientific Corp / cleared 2013-11-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)