Recall Z-1170-2021— Boston Scientific Corporation

Name: FDA recall Z-1170-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-19

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2021-01-19. It names one FDA 510(k) clearance: K131700. 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..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2021-01-19
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K131700 — SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARESBoston Scientific Corp·cleared 2013-11-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.