Recall Z-1336-2009 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Corporation
Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION M001201050 VSKCL-12 M001201060 VSKCL-14 M001202020 VSDCL-12 M001202030 VSDCL-14 M001203060 VSCL-12 M001203070 VSCL-14 Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, M
| Date | May 21, 2009 (initiated Mar 18, 2009) |
| Status | Terminated |
| 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 Re |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K811378 | PERCUTANEOUS DRAINING CATHETER Medi-Tech, Inc., Jun 2, 1981 |