Recall Z-1333-2009 ยท FFA Tube, Drainage, Suprapubic
Boston Scientific Corporation
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
| 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
| K944290 | CATHETERS, BILIARY CATHETERS, UROLOGICAL Boston Scientific Corp, Dec 8, 1994 |