—#80177

Product

Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN DESCRIPTION M001271540 FLEXIMA BILIARY FIRM 8F/35CM M001271550 FLEXIMA BILIARY FIRM 10F/35CM M001271560 FLEXIMA BILIARY REG 8F/35CM M001271570 FLEXIMA BILIARY REG 10F/35CM M001271580 FLEXIMA BILIARY REG 12F/35CM M001271590 FLEXIMA BILIARY REG 14F/35CM M001271600 FLEXIMA BILIARY SOFT 10F/35CM M001271610 FLEXIMA BILIARY SOFT 12F/35CM M001271620 FLEXIMA BILIARY SOFT 14F/35CM M001281560 FLEXIMA BILIARY 8/35 TT M001281570 FLEXIMA BILIARY 10/35 TT M001281580 FLEXIMA BILIARY 12/35 TT M001281590 FLEXIMA BILIARY 14/35 TT M001271630 FLEXIMA BIL 8F/35CM FIRM KIT M001271640 FLEXIMA BIL 10F/35CM FIRM KIT M001271650 FLEXIMA BIL 8F/35CM REG KIT M001271660 FLEXIMA BIL 10F/35CM REG KIT 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 product code: FFA — Tube, Drainage, Suprapubic
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K944290
Affected lot / code info: All codes

Why it was recalled

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.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

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.

Timeline

Recall initiated: 2009-03-18
Posted by FDA: 2009-05-21
Terminated: 2012-02-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #80177. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.