—#91343

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.

FDA product code: DQX — Wire, Guide, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K011906, K020283
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-04-19
Posted by FDA: 2010-06-04
Terminated: 2011-12-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91343. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.