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U.S. Department of Health and Human Services

Class 3 Device Recall Boston Scientific PT2 Guide Wire

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 Class 3 Device Recall Boston Scientific PT2 Guide Wiresee related information
Date Initiated by FirmAugust 31, 2006
Date PostedSeptember 29, 2006
Recall Status1 Terminated 3 on June 26, 2007
Recall NumberZ-1539-06
Recall Event ID 36201
510(K)NumberK030617 
Product Classification Guide Wire - Product Code DQX
ProductBoston Scientific PT2 Light Support Guide Wire 300cm J-Tip, Catalog Number 38931-02 . Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip. Made in USA.
Code Information Single Pack - Outer Box UPN H7492893102J0, Inner Pouch UPN H7493893102J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8616992/8498451; 8634476/8576268; 8637834/8592512; 8642641/8542687; 8687373/8644753; 8687380/8620072; 8693389/8644751.   5-pack - Outer Box UPN H7493893102J2, Inner Pouch UPN H7493893102J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8616993/8498451; 8619932/8428652; 8634477/8576268; 8637835/8592512; 8642642/8542687; 8687374/8644753; 8687381/8620072; 8693471/8644751; 8745684/8677736.
Recalling Firm/
Manufacturer		 Boston Scientific
1 Scimed Pl
Maple Grove MN 55311-1565
Manufacturer Reason
for Recall		The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip.
FDA Determined
Cause 2		Other
ActionAn Urgent Medical Device Recall letter, dated 08/31/06, was sent to affected customers. The letter describes the issue,states that distribution or use of affected product should cease immediately and replacement product will be issued for all returned devices. A Reply Verification Tracking Form is asked to be completed and returned to Boston Scientific.
Quantity in Commerce115 total. 103-US, 12-Foreign
DistributionWorldwide distribution --- including states of AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NV, OH, OK, PA, SC, TN, TX, WI, WV and Puerto Rico and countries of Austria, Belgium, Bulgaria, Chile, Columbia, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Malaysia, Mexico, Norway, Pakistan, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DQX
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