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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific, BackUp Meier Steerable Guidewires

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  Class 2 Device Recall Boston Scientific, BackUp Meier Steerable Guidewires see related information
Date Initiated by Firm April 19, 2010
Date Posted June 04, 2010
Recall Status1 Terminated 3 on December 10, 2011
Recall Number Z-1760-2010
Recall Event ID 55620
510(K)Number K011906  K020283  
Product Classification Wire, guide, catheter - Product Code DQX
Product Boston Scientific, Back-Up Meier Steerable Guidewires, Sterilized using ethylene oxide.

The steerable guidewires are made of a stainless-steel, PTFE-coated proximal shaft, which tapers down to a very flexible and shapeable distal tip. The tip area consists of a radio-opaque gold-plated tungsten spring coil wound around a stainless-steel inner core. The usable length of the guidewire is 185 cm, 260 cm and 300 cm.

Material (UPN) H965SCH306000; Catalog # SCH-30600; Product Description / Number BACK-UP MEIER .035 in, 185cm FLEX J TIP, Single / Single.

Material (UPN) H965SCH306001; Catalog # SCH-30600; Product Description / Number BACK-UP MEIER .035 in, 185cm, J TIP B5 /5 per Box.

Material (UPN) H965SCH306010; Catalog # SCH-30601; Product Description / Number BACK-UP MEIER .035 in, 300cm EX, FLEX C, Single/ Single.

Material (UPN) H965SCH306011; Catalog # SCH-30601; Product Description / Number BACK-UP MEIER .035 in, 300cm EX C TIP B5/5 per Box.

Material (UPN) M001306020; Catalog # 30-602; Product Description / Number MEIER WIRE 260 cm .035 w/C TIP, SINGLE/Single.

Material (UPN) M001306021; Catalog # 30-602; Product Description / Number MEIER WIRE 260 cm .035 w/C TIP 5 PER BX/5 per Box.
Code Information Lot/Batch 13188299 13188448 13188850 13189372 13191119 13191900 13214230 13215622 13217713 13218224 13218422 13218654 13230493 13231032 13231763 13235212 13237044 13237266 13237865 13244785 13245496 13250396 13250705 13250811 13255106 13188299 13188448 13188850 13189372 13191119 13191900 13214230 13215622 13217713 13218224 13218422 13218654 13230493 13231032 13231763 13235212 13237044 13237266 13237865 13244785 13245496 13250396 13250705 13250811 13255106 13168826 13188292 13189005 13191912 13192123 13192691 13194328 13205603 13212484 13212647 13214988 13220752 13223805 13224584 13225209 13230183 13230872 13235343 13235437 13237414 13240493 13241294 13244517 13245964 13253646 13260267 13168826 13188292 13189005 13191912 13192123 13192691 13194328 13205603 13212484 13212647 13214988 13220752 13223805 13224584 13225209 13230183 13230872 13235343 13235437 13237414 13240493 13241294 13244517 13245964 13253646 13260267 13189367 13200586 13213574 13217494 13241577 13254666 13189367 13200586 13213574 13217494 13241577 13254666 
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact
763-494-1700
Manufacturer Reason
for Recall		 Boston Scientific Corporation is conducting a Medical Device Recall of certain lots/batches of its Back-up Meier Steerable Guidewires. Through their internal inspection process, they identified that the polytetrafluoroethylene (PTFE) coating on the gold plated distal coil of the Back-up Meier Steerable Guidewires of the identified lots/batches have the potential for PTFE delamination. Inconsist
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were sent a Boston Scientific "Urgent Medical Device Recall" letter dated April 19, 2010. The letter was addressed to Risk Manger/Field Action Contact. The letter described the problem and product affected and recommended that to immediately discontinue use of and segregate recalled product. They also requested the consignee to complete and return the Account Reply Verification Tracking Form. Customers with questions are directed to the firm's Field Action Coordinator at (763-) 494-1417.
Quantity in Commerce US 885 single units (177 boxes), OUS 630 single units (126 boxes)
Distribution AL, AZ, AR, CA, CT, FL, GA, IL, IN, IA, KS, KY, ME, MD, MA, MS, MO, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN TX, VT, VA, WA. SWITZERLAND, GERMANY, FINLAND, FRANCE, ITALY, JORDAN, POLAND, SWEDEN, CANADA. Complete consignee list not available at this time.
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 CORP.
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