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U.S. Department of Health and Human Services

Class 2 Device Recall Stingray Catheter

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  Class 2 Device Recall Stingray Catheter see related information
Date Initiated by Firm June 26, 2012
Date Posted July 24, 2012
Recall Status1 Terminated 3 on September 06, 2012
Recall Number Z-2074-2012
Recall Event ID 62450
510(K)Number K080987  K101591  K102725  
Product Classification Catheter, percutaneous - Product Code DQY
Product BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441.

Stingray" Catheters are intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent intervention. When used as part of the BridgePoint Medical System, the Stingray Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention. .
Code Information Lots affected in US: BP20121440078, BP20121560089 Lots affected OUS: BP20121510086, BP20121500080
Recalling Firm/
Manufacturer		 Bridgepoint Medical
13355 10th Ave N
Suite #110
Minneapolis MN 55441-5553
For Additional Information Contact
763-225-8511
Manufacturer Reason
for Recall		 BridgePoint Medical Inc. is voluntarily recalling Stingray Catheter, Model M1000 lots BP20121440078 and BP20121560089. BridgePoint Medical, Inc. recently determined the potential of compromised sterility assurance of the product due to a faulty pouch seal. In no case was there any reported adverse clinical event related to the problem.
FDA Determined
Cause 2		 Process control
Action The firm, BridgePoint Medical, sent an "Urgent Field Safety Notice" letter dated June 26, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory, quarantine the affected lots and complete and return the enclosed "Verification Form" via fax to 763-225-8718 ,attn: BridgePoint Medical, Inc., Upon receipt of form, BridgePoint will supply the customers with the appropriate materials to return the products. If you have any questions regarding this notice, please call BridgePoint Medical, Vice President of Quality Assurance, at 763-225-8511 or e-mail at cschlawin@bridgepointmedical.com.
Quantity in Commerce 95 (57 USA, 38 OUS)
Distribution Worldwide distribution: USA (nationwide) including: AL, AZ, CA, CO, GA, IL, KY, MD, MN, MO, NC, NY, OR, PA, WA, and WI; and countries of: Australia and Sweden.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = BRIDGE MEDICAL, INC.
510(K)s with Product Code = DQY and Original Applicant = BRIDGEPOINT MEDICAL
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