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Terminated

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 Recall Z-1760-2010 · Posted 2010-06-04

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDQX
Date Initiated2010-04-19
Date Terminated2011-12-10
Product QuantityUS 885 single units (177 boxes), OUS 630 single units (126 boxes)

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

Firm 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.

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020283BACK-UP MEIER STEERABLE GUIDEWIREBoston Scientific Corp · 2002-02-11K011906BACK-UP MEIER GUIDEWIREBoston Scientific Corp · 2001-08-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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