Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; M00561222 (Box 20), M00561220; M00561223 (Box 40), M00561220; M00561233 (Box 40), M00561230.

FDA Recall Z-1169-2021 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeFDI
Date Initiated2021-01-19
Product Quantity335,788 units total (Domestic: 222,882, Foreign: 112,906)

Reason for Recall

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

Firm 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.

Root Cause

Process change control

Distribution Pattern

US nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑