Cook Endoscopy: 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.

Recall number

Z-0925-2011

Recalling firm

Cook Endoscopy

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.

Status

Terminated

Initiated

2010-12-23

Posted

2011-01-19

Terminated

2011-08-04

Reason

Product defect; There is a risk of gastrointestinal perforation due to balloon deflation difficulty or air embolism resulting in poor patient outcomes including death.

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 CustomerRelationsNA@cookmedical.com. 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 CustomerRelationsNA@cookmedical.com or call toll free at 1-800-457-4500, press 4 then enter extension 2146.

Quantity

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..

Lot, serial or model codes

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.

510(k) numbers

["K101095"]

PMA numbers

not on file

Product code

FGE

Firm FEI

1037905

Firm city

Winston Salem

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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