Z-1331-2009

Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN DESCRIPTION M001271770...

Name: Z-1331-2009 Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN DESCRIPTION M001271770...
Creator: Boston Scientific Corporation
Published: 2009-03-18
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2009-03-18 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN DESCRIPTION M001271770 FLEXIMA NEPH FIRM 8F/25CM M001271780 FLEXIMA NEPH... on 2009-03-18. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1331-2009
Status: Terminated
Initiated: 2009-03-18
Posted: 2009-05-21
Terminated: 2012-02-23
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN DESCRIPTION M001271770 FLEXIMA NEPH FIRM 8F/25CM M001271780 FLEXIMA NEPH FIRM 10F/25CM M001271790 FLEXIMA NEPH REG 8F/25CM M001271800 FLEXIMA NEPH REG 10F/25CM M001271810 FLEXIMA NEPH REG 12F/25CM M001271820 FLEXIMA NEPH REG 14F/25CM M001271830 FLEXIMA NEPH SOFT 10F/25CM M001271840 FLEXIMA NEPH SOFT 12F/25CM M001271850 FLEXIMA NEPH SOFT 14F/25CM M001281790 FLEXIMA NEPHROSTOMY 8/25 TT M001281800 FLEXIMA NEPHROSTOMY 10/25 TT M001281810 FLEXIMA NEPHROSTOMY 12/25 TT M001281820 FLEXIMA NEPHROSTOMY 14/25 TT M001271860 FLEXIMA NEPH 8F/25CM REG KIT M001271870 FLEXIMA NEPH 10F/25CM REG KIT M001271880 FLEXIMA NEPH 12F/25CM REG KIT M001271890 FLEXIMA NEPH 14F/25CM REG KIT M001271900 FLEXIMA NEPH 8F/25CM FIRM KIT M001271910 FLEXIMA NEPH 10F/25CM FIRM KIT M001281650 FLEXIMA NEPH 8/25 TEMP TIP KIT M001281660 FLEXIMA NEPH/10/25 TEMPTIP KIT Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scientific Corporation, One Boston Scientific 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.
Product code: FFA Tube, Drainage, Suprapubic
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: All codes

Product code FFA

K944290Class IICatheters, Biliary Catheters, UrologicalBoston Scientific Corp / cleared 1994-12-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)