Z-1168-2021Class II

Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch...

Name: Z-1168-2021 Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch...
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 Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561310 M00562301 (Box... 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-1168-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-01-19
Posted: 2021-03-04
Recalling firm: Boston Scientific Corporation
Product: Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561310 M00562301 (Box 10), M00562300; M00562321 (Box 10), M00562320; M00562341 (Box 10), M00562340; M00562451 (Box 10), M00562450; M00562401 (Box 10), M00562400; M00562402 (Box 40), M00562400; M00562422 (Box 40), M00562420; M00562471 (Box 10), M00562470.
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: 08714729019251 Inner pouch GTIN: 08714729747680 Lot/Batch#: 24725319, 24782695, Outer box GTIN: 08714729019312 Inner pouch GTIN: 08714729747833 Lot/Batch#: 24842597, 24812577, Outer box GTIN: 08714729019336 Inner pouch GTIN: 08714729747857 Lot/Batch#: 24889757, 24719202, 24709536, 24773287, Outer box GTIN: 08714729019350 Inner pouch GTIN: 08714729747871 Lot/Batch#: 24782693, 24732964, 24889755, 24780939, Outer box GTIN: 08714729071068 Inner pouch GTIN: 08714729747970 Lot/Batch#: 24882357, 24782689, 24782687, 24729758, Outer box GTIN: 08714729019411 Inner pouch GTIN:08714729747932 Lot/Batch#: 24961643 Outer box GTIN:08714729501640 Inner pouch GTIN: 08714729747932 Lot/Batch#: 24961645, 24989260, 24844193, Outer box GTIN:08714729501657 Inner pouch GTIN:08714729747956 Lot/Batch#: 25010054, Outer box GTIN:08714729019459 Inner pouch GTIN:08714729747994 Lot/Batch#: 25016793.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1168-2021
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

K202478Class IICaptivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy SnaresBoston Scientific Corporation / cleared 2020-10-08

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)