Recall Z-1343-2009
Boston Scientific Corporation · initiated March 18, 2009
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.
Codes / lots: All codes
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.
FDA-determined cause: Labeling False and Misleading
Action taken
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.
Details
- Recall number
- Z-1343-2009
- Initiated
- March 18, 2009
- Posted by FDA
- May 21, 2009
- Terminated
- February 23, 2012
- Product code
- FGE – Stents, Drains And Dilators For The Biliary Ducts
- 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…
- Recalling firm
- Boston Scientific Corporation, Maple Grove, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1331-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN…Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex… | 03/18/2009Terminated |
| Z-1332-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN…Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex… | 03/18/2009Terminated |
| Z-1333-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN…Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex… | 03/18/2009Terminated |
| Z-1334-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#…Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex… | 03/18/2009Terminated |
| Z-1335-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#…Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex… | 03/18/2009Terminated |
| Z-1336-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#…Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex… | 03/18/2009Terminated |
| Z-1337-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#…Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex… | 03/18/2009Terminated |
| Z-1338-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#…Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex… | 03/18/2009Terminated |
| Z-1339-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#…Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex… | 03/18/2009Terminated |
| Z-1340-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#…Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex… | 03/18/2009Terminated |
| Z-1341-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#…Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex… | 03/18/2009Terminated |
| Z-1342-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#…Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex… | 03/18/2009Terminated |
| Z-1344-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#…Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex… | 03/18/2009Terminated |
| Z-1345-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN #…Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex… | 03/18/2009Terminated |
| Z-1346-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#…Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex… | 03/18/2009Terminated |
| Z-1347-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#…Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex… | 03/18/2009Terminated |