Z-0925-2011

DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical, Winston-Salem, NC 27105 This...

Name: Z-0925-2011 DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical, Winston-Salem, NC 27105 This...
Creator: Cook Endoscopy
Published: 2010-12-23
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2010-12-23 / Terminated

FDA source

Cook Endoscopy began a recall of DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical, Winston-Salem, NC 27105 This device is intended to guide both optical and... on 2010-12-23. The reason FDA records is "Product defect; There is a risk of gastrointestinal perforation due to balloon deflation difficulty or air embolism resulting in poor patient outcomes including death". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0925-2011
Status: Terminated
Initiated: 2010-12-23
Posted: 2011-01-19
Terminated: 2011-08-04
Recalling firm: Wilson-Cook Medical Inc.
Product: DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical, Winston-Salem, NC 27105 This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Product defect; There is a risk of gastrointestinal perforation due to balloon deflation difficulty or air embolism resulting in poor patient outcomes including death.
FDA root cause: Other
Action: The firm, Cook Medical, sent an "URGENT: PRODUCT RECALL" letter dated January 7, 2011, to all customers. The letter described the product, problem and the actions to be taken by the customers. The customers were instructed to quarantine any affected product and return to Cook Medical. If they are distributors, they were instructed to contact their customers, direct them to quarantine any affected product and coordinate the return of the affected product to Cook Medical. The customers were also instructed to complete and return the bottom of the letter and send to Cook Medical as well as the PRODUCT RECALL EFFECTIVENESS SURVEY via fax at 812-339-7316 or scanned and emailed to [email protected]. Note: All non-responding customers will receive a total of three (3) recall notifications ( two (2) follow up requests for a response in addition to the initial recall notification). Should you have any questions, please contact the Customer Relations Department at Cook Medical for more information. Please use [email protected] or call toll free at 1-800-457-4500, press 4 then enter extension 2146.
Quantity in commerce: 103 units (total for both units under recall)
Distribution: Worldwide distribution: USA including states of: AL, CA, FL, IL, IN, LA, MA, NC, NY, OH, PA, SC, TN, TX, WA, and WI; and countries of: Belgium, Canada, Germany, Hong Kong, and the Netherlands..
Product codes and lots: Reorder number: DPOC-15, Lot numbers: W2834630, W2835211, W2871208, W2871209, W2889215, W2889216, W2889217, W2889218, W2899398, W2899399, W2902200, W2902201, W2907649, W2907650, W2910395, W2910396, W2914136, W2914137, W2916501, W2916502, W2918945, W2918946, W2920993, W2920994, W2926799, W2926800, W2928562, W2928563, W2930338, W2930882, W2932781, W2932858, W2935202, W2935243 and WR2926438.

Product code FGE

K101095Class IIDirect Peroral Cholangioscopy BalloonWilson-Cook Medical, Inc. / cleared 2010-07-19

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)