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Terminated

Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION M001221000 AA/8/30 M001221010 AA/10/30 M001221020 AA/12/30 Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.

FDA Recall Z-1335-2009 · Posted 2009-05-21

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeFGE
Date Initiated2009-03-18
Date Terminated2012-02-23
Product Quantity586,276 US; 276,013 OUS total for all products

Reason for Recall

Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and remained in the patient.

Firm Action

Consignees were sent a Boston Scientific " Urgent Medical Device Field Correction Notification" letter dated March 18, 2009. The letter was addressed to "The Hospital Field Action Contact". The letter described the problem, product affected and the revised catheter removal instructions. They also requested the return of the Acknowledgement Form.

Root Cause

Labeling False and Misleading

Distribution Pattern

Worldwide Distribution -- USA including DC, Puerto Rico and Guam and countries of United Arab Emirates Austria, Bosnia and Herzegovina, Bahrain, Switzerland, Germany, Egypt, Spain, Finland, France, Great Britain, Ireland, Italy, Kuwait, Netherland, Pakistan, Portugal, Saudi Arabia, Sweden, Slovak Republic, Tunisia, Turkey, South Africa, Netherlands, Costa Rica, Japan, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Macau, Malaysia, Mexico New Zealand, Panama, Peru, Philippines, Puerto Rico, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay, and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K811378PERCUTANEOUS DRAINING CATHETERMedi-Tech, Inc. · 1981-06-02

Official Source

View FDA Recall →

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

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