FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION M001231360 IE TEMP TIP 8/22 M001231370 IE TEMP TIP 8/24 M001231380 IE TEMP TIP 8/26 M001231390 IE TEMP TIP 8/28 M001231400 IE TEMP TIP 10/22 M001231410 IE TEMP TIP 10/24 M001231420 IE TEMP TIP 10/26 M001231430 IE TEMP TIP 10/28 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.
- Recall number
- Z-1343-2009
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION M001231360 IE TEMP TIP 8/22 M001231370 IE TEMP TIP 8/24 M001231380 IE TEMP TIP 8/26 M001231390 IE TEMP TIP 8/28 M001231400 IE TEMP TIP 10/22 M001231410 IE TEMP TIP 10/24 M001231420 IE TEMP TIP 10/26 M001231430 IE TEMP TIP 10/28 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.
- Status
- Terminated
- Initiated
- 2009-03-18
- Posted
- 2009-05-21
- Terminated
- 2012-02-23
- Reason
- 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
- Labeling False and Misleading
- 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.
- Quantity
- 586,276 US; 276,013 OUS total for all products
- Distribution
- 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.
- Lot, serial or model codes
- All codes
- 510(k) numbers
- ["K900205"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28