FDA Device recall Z-1170-2021

Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310

FDA Device
Class II
ongoing
Published 2021-03-10

On 2021-03-10 the FDA classified a Class II recall of Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310 by Boston Scientific, citing packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1170-2021
Classification	Class II
Status	ongoing
Initiated	2021-01-19
Published	2021-03-10
Last updated	2026-09-13 11:56 UTC
Company	Boston Scientific
Distribution	US

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.

Reason

Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

Identifiers

code_info	Outer box GTIN: 08714729283904 Inner pouch GTIN: 08714729747598 Lot/Batch#: 24818278, 24906823, 25042455 Outer box… 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,

code_info

Outer box GTIN: 08714729283904 Inner pouch GTIN: 08714729747598 Lot/Batch#: 24818278, 24906823, 25042455 Outer box…

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,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1170-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.