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Class 2 Device Recall Stingray Catheter |
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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
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Product Classification |
Catheter, percutaneous - Product Code DQY
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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
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For Additional Information Contact |
763-225-8511
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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.
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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
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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.
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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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