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U.S. Department of Health and Human Services

Class 2 Device Recall PT Graphix Magnet JTIP Guidewire with ICE Hydrophilic Coating

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  Class 2 Device Recall PT Graphix Magnet JTIP Guidewire with ICE Hydrophilic Coating see related information
Date Initiated by Firm March 28, 2016
Create Date April 12, 2016
Recall Status1 Terminated 3 on November 07, 2016
Recall Number Z-1370-2016
Recall Event ID 73719
510(K)Number K143587  
Product Classification Wire, guide, catheter - Product Code DQX
Product Boston Scientific, PT Graphix Magnet J-TIP Guidewire
with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label) ,H7491490201MJo (UPN referenced on the Pouch Label) .

Boston Scientific PT Graphix Magnet Guidewire with ICE Hydrophilic Coating is a steerable guidewire available with a nominal diameter of 0.014 in (0.37 mm) and in nominal lengths of 182 cm. PT Graphix Magnet is available with a shapeable Straight Tip or a preformed "J"¿ Tip.
The PT Graphix Magnet Guidewire features a 10 or 38 cm polymer sleeve, coated with ICE Hydrophilic Coating, jacketing the distal tapered core wire. The proximal section of the PT Graphix Magnet Guidewire is coated with a fluorinated polymer.
Code Information Lot: 17971870
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
2 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact Nicole Pshon
763-494-1556
Manufacturer Reason
for Recall		 Boston Scientific is voluntarily implementing a Medical Device Recall of one batch of PT Graphix Magnet J-TIP Guidewires. Boston Scientific has found that, while the batch is labeled as a J-tip model, the guidewires are straight and do not have the pre-formed J-tip. The most severe injury expected to occur is a limited procedure delay caused by the need to replace the guidewire with one that has
FDA Determined
Cause 2		 Process control
Action Boston Scientific sent an "Urgent Medical Device Recall" letter dated March 28, 2016. The letter was addressed to Cath Lab Materials Manager / Field Action Contact. The letter described the problem and the product affected by the recall. Advised consignees to cease immediately further distribution or use of the product and to notify their customers. They also requested consignees to complete and return "The Reply Verification Tracking Form" For questions contact your local Boston scientific sales Representative of the Boston Scientific Filed Action Center..
Quantity in Commerce 47 units
Distribution US nationwide in the states of ME, LA, and TN
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 = DQX and Original Applicant = BOSTON SCIENTIFIC CORPORATION
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